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NCT05131971

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants

Completed Phase 1 Results posted Last updated 26 March 2025
What this trial tests

Phase 1 trial testing GSK3888130B in Multiple Sclerosis in 54 participants. Completed in 12 October 2023.

Timeline
1 November 2021
Primary endpoint
12 October 2023
12 October 2023

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposetreatment
Enrollment54
Start date1 November 2021
Primary completion12 October 2023
Estimated completion12 October 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis or Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · Up to 160 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

AEs
GroupValue95% CI
Placebo8
GSK3888130B Dose Level 1 IV3
GSK3888130B Dose Level 2 IV2
GSK3888130B Dose Level 3 SC6
GSK3888130B Dose Level 4 IV2
GSK3888130B Dose Level 5 SC4
GSK3888130B Dose Level 6 IV8
GSK3888130B Dose Level 7 IV5
SAEs
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Clinically Significant Changes in Hematology Results Primary · Up to 85 days

Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.

GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline Primary · Baseline (Day 1) and up to 85 days

Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5\*10\^9 cells/Liter (L), Grade 1: \<0.5 to 0.2\*10\^9 cells/L, Grade 2: \<0.2 to 0.05\*10\^9 cells/L, Grade 3: Below 0.05\*10\^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

Increase to Grade 1
GroupValue95% CI
Placebo4
GSK3888130B Dose Level 1 IV1
GSK3888130B Dose Level 2 IV1
GSK3888130B Dose Level 3 SC1
GSK3888130B Dose Level 4 IV1
GSK3888130B Dose Level 5 SC3
GSK3888130B Dose Level 6 IV5
GSK3888130B Dose Level 7 IV4
Increase to Grade 2
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Increase to Grade 3
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline Primary · Baseline (Day 1) and up to 85 days

Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: \<1.5\* Baseline, or increase from Baseline \<26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9\* Baseline, or increase from Baseline \>=26 umol/L, Grade 2: 2.0 to 2.9\* Baseline, Grade 3: \>=3.0\* Baseline, or \>=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

Increase to Grade 1
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV1
GSK3888130B Dose Level 7 IV0
Increase to Grade 2
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Increase to Grade 3
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Clinically Significant Changes in Clinical Chemistry Results Primary · Up to 85 days

Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.

GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline Primary · Baseline (Day 1) and up to 85 days

Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any incr

Bilirubin
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Erythrocytes
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC1
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC2
GSK3888130B Dose Level 6 IV1
GSK3888130B Dose Level 7 IV0
Glucose
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC1
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Ketones
GroupValue95% CI
Placebo1
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV1
Leukocytes
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Nitrite
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV1
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Protein
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV1
GSK3888130B Dose Level 7 IV2
Specific Gravity
GroupValue95% CI
Placebo8
GSK3888130B Dose Level 1 IV3
GSK3888130B Dose Level 2 IV2
GSK3888130B Dose Level 3 SC4
GSK3888130B Dose Level 4 IV5
GSK3888130B Dose Level 5 SC6
GSK3888130B Dose Level 6 IV5
GSK3888130B Dose Level 7 IV6
Number of Participants With Clinically Significant Changes in Vital Sign Results Primary · Up to 85 days

Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.

GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA Primary · Baseline (Day 1), Day 15 and Day 85

VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.

Cytomegalovirus DNA, Baseline (Day 1)
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Cytomegalovirus DNA, Day 15
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Cytomegalovirus DNA, Day 85
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Varicella Zoster Virus DNA, Baseline (Day 1)
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Varicella Zoster Virus DNA, Day 15
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Varicella Zoster Virus DNA, Day 85
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA Primary · Baseline (Day 1), Day 15 and Day 85

EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive \>=LLQ' and 'Positive \< LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values \>=LLQ were categorized as 'Positive \>=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \<LLQ were categorized as 'Positive \<LLQ'. This represents a positive result that is below the assay limit of quantification. Baseline was defined as the latest pre-dose assessment.

Baseline (Day 1), Positive < LLQ
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV1
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC1
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV1
Baseline (Day 1), Positive >= LLQ
GroupValue95% CI
Placebo2
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC1
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV2
Day 15, Positive < LLQ
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV1
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV2
GSK3888130B Dose Level 7 IV1
Day 15, Positive >= LLQ
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV1
GSK3888130B Dose Level 7 IV0
Day 85, Positive < LLQ
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
Day 85, Positive >= LLQ
GroupValue95% CI
Placebo1
GSK3888130B Dose Level 1 IV1
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV1
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV1
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Primary · Up to 85 days

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.

CLINICALLY SIGNIFICANT
GroupValue95% CI
Placebo0
GSK3888130B Dose Level 1 IV0
GSK3888130B Dose Level 2 IV0
GSK3888130B Dose Level 3 SC0
GSK3888130B Dose Level 4 IV0
GSK3888130B Dose Level 5 SC0
GSK3888130B Dose Level 6 IV0
GSK3888130B Dose Level 7 IV0
NOT CLINICALLY SIGNIFICANT
GroupValue95% CI
Placebo12
GSK3888130B Dose Level 1 IV1
GSK3888130B Dose Level 2 IV2
GSK3888130B Dose Level 3 SC6
GSK3888130B Dose Level 4 IV4
GSK3888130B Dose Level 5 SC6
GSK3888130B Dose Level 6 IV7
GSK3888130B Dose Level 7 IV5
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration Secondary · Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

DAY 1 (Pre-dose)
GroupValue95% CI
GSK3888130B Dose Level 1 IVNANA – NA
GSK3888130B Dose Level 2 IVNANA – NA
GSK3888130B Dose Level 4 IVNANA – NA
DAY 1 (15 Minutes)
GroupValue95% CI
GSK3888130B Dose Level 1 IV363.2196.7 – 670.9
GSK3888130B Dose Level 2 IV2155.91003.0 – 4634.4
GSK3888130B Dose Level 4 IV15901.113993.4 – 18069.0
DAY 1 (30 Minutes)
GroupValue95% CI
GSK3888130B Dose Level 1 IV893.1504.7 – 1580.5
GSK3888130B Dose Level 2 IV4717.53173.3 – 7013.1
GSK3888130B Dose Level 4 IV35633.030628.5 – 41455.2
DAY 1 (4 Hours)
GroupValue95% CI
GSK3888130B Dose Level 1 IV761.4677.2 – 856.1
GSK3888130B Dose Level 2 IV4497.02542.8 – 7953.0
GSK3888130B Dose Level 4 IV32762.828319.4 – 37903.3
DAY 1 (8 Hours)
GroupValue95% CI
GSK3888130B Dose Level 1 IV753.5483.7 – 1173.8
GSK3888130B Dose Level 2 IV3964.21974.7 – 7958.0
GSK3888130B Dose Level 4 IV31180.827855.3 – 34903.4
DAY 1 (12 Hours)
GroupValue95% CI
GSK3888130B Dose Level 1 IV758.1601.3 – 955.8
GSK3888130B Dose Level 2 IV3599.92601.7 – 4981.2
GSK3888130B Dose Level 4 IV29821.826986.2 – 32955.3
DAY 1 (24 Hours)
GroupValue95% CI
GSK3888130B Dose Level 1 IV720.8558.6 – 930.0
GSK3888130B Dose Level 2 IV3781.52095.7 – 6823.7
GSK3888130B Dose Level 4 IV28096.626173.0 – 30161.6
DAY 1 (48 Hours)
GroupValue95% CI
GSK3888130B Dose Level 1 IV572.8401.3 – 817.7
GSK3888130B Dose Level 2 IV3184.02280.6 – 4445.1
GSK3888130B Dose Level 4 IV23358.320418.2 – 26721.8
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration Secondary · Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following subcutaneous administration.

DAY 1 (Pre-dose)
GroupValue95% CI
GSK3888130B Dose Level 3 SCNANA – NA
GSK3888130B Dose Level 5 SCNANA – NA
DAY 1 (4 Hours)
GroupValue95% CI
GSK3888130B Dose Level 3 SCNANA – NA
GSK3888130B Dose Level 5 SC2540.41193.5 – 5407.6
DAY 1 (8 Hours)
GroupValue95% CI
GSK3888130B Dose Level 3 SCNANA – NA
GSK3888130B Dose Level 5 SC5287.22659.9 – 10509.8
DAY 1 (12 Hours)
GroupValue95% CI
GSK3888130B Dose Level 3 SCNANA – NA
GSK3888130B Dose Level 5 SC8236.84122.6 – 16456.5
DAY 1 (24 Hours)
GroupValue95% CI
GSK3888130B Dose Level 3 SC1284.2795.2 – 2073.7
GSK3888130B Dose Level 5 SC14161.97502.7 – 26731.7
DAY 1 (48 Hours)
GroupValue95% CI
GSK3888130B Dose Level 3 SC2297.01506.7 – 3501.9
GSK3888130B Dose Level 5 SC23239.012191.4 – 44297.5
DAY 6
GroupValue95% CI
GSK3888130B Dose Level 3 SC3253.72339.4 – 4525.5
GSK3888130B Dose Level 5 SC34612.825180.0 – 47579.2
DAY 8
GroupValue95% CI
GSK3888130B Dose Level 3 SC3327.12422.0 – 4570.5
GSK3888130B Dose Level 5 SC34801.725828.6 – 46892.0

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/15 (0%)
Deaths: 0/15
GSK3888130B Dose Level 1 IV
Serious: 0/3 (0%)
Deaths: 0/3
GSK3888130B Dose Level 2 IV
Serious: 0/3 (0%)
Deaths: 0/3
GSK3888130B Dose Level 3 SC
Serious: 0/6 (0%)
Deaths: 0/6
GSK3888130B Dose Level 4 IV
Serious: 0/6 (0%)
Deaths: 0/6
GSK3888130B Dose Level 5 SC
Serious: 0/6 (0%)
Deaths: 0/6
GSK3888130B Dose Level 6 IV
Serious: 0/9 (0%)
Deaths: 0/9
GSK3888130B Dose Level 7 IV
Serious: 0/6 (0%)
Deaths: 0/6
Other adverse events (45 terms — click to expand)

ReactionSystemPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
COVID-19Infections and infestations
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
HypertransaminasaemiaHepatobiliary disorders
InfluenzaInfections and infestations
Nasal congestionRespiratory, thoracic and mediastinal disorders
Dermatitis contactSkin and subcutaneous tissue disorders
NeutropeniaBlood and lymphatic system disorders
Ear painEar and labyrinth disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
NauseaGastrointestinal disorders
ToothacheGastrointestinal disorders
Catheter site painGeneral disorders
Catheter site rashGeneral disorders
FatigueGeneral disorders
Influenza like illnessGeneral disorders
Injection site pruritusGeneral disorders
MalaiseGeneral disorders
Swelling faceGeneral disorders
Seasonal allergyImmune system disorders
Acne pustularInfections and infestations
CellulitisInfections and infestations
Infected cystInfections and infestations
Lower respiratory tract infectionInfections and infestations
Oral herpesInfections and infestations
Arthropod biteInjury, poisoning and procedural complications
ContusionInjury, poisoning and procedural complications
Ligament sprainInjury, poisoning and procedural complications
Procedural painInjury, poisoning and procedural complications
Aspartate aminotransferase increasedInvestigations
Blood creatine phosphokinase increasedInvestigations
Blood pressure diastolic increasedInvestigations
Blood pressure increasedInvestigations
Haemoglobin decreasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Head discomfortNervous system disorders
ParaesthesiaNervous system disorders

Data from ClinicalTrials.gov NCT05131971 adverse events section.

Sponsor's own description

This is a first time in human study designed to assess the safety, tolerability, pharmacokinetics and PD of GSK3888130B over a range of dose levels in healthy participants.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting γc family cytokines with biologics: current status and future prospects.
    Bick F, Blanchetot C, Lambrecht BN, Schuijs MJ. · · 2025 · cited 5× · PMID 39967341 · DOI 10.1080/19420862.2025.2468312
  2. Comparative Efficacy of Interleukin-7 and -15 Blockade in Alleviating Experimental Chronic Uveitis and Suppressing Pathogenic Memory CD4+ T Cells.
    Zhu Q, Shayan M, Huckfeldt RM, Chen Y. · · 2025 · cited 2× · PMID 40323267 · DOI 10.1167/iovs.66.5.9

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05131971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing