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
Group
Value
95% CI
Placebo
8
GSK3888130B Dose Level 1 IV
3
GSK3888130B Dose Level 2 IV
2
GSK3888130B Dose Level 3 SC
6
GSK3888130B Dose Level 4 IV
2
GSK3888130B Dose Level 5 SC
4
GSK3888130B Dose Level 6 IV
8
GSK3888130B Dose Level 7 IV
5
SAEs
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Clinically Significant Changes in Hematology ResultsPrimary· 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.
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to BaselinePrimary· 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
Group
Value
95% CI
Placebo
4
GSK3888130B Dose Level 1 IV
1
GSK3888130B Dose Level 2 IV
1
GSK3888130B Dose Level 3 SC
1
GSK3888130B Dose Level 4 IV
1
GSK3888130B Dose Level 5 SC
3
GSK3888130B Dose Level 6 IV
5
GSK3888130B Dose Level 7 IV
4
Increase to Grade 2
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Increase to Grade 3
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to BaselinePrimary· 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
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
1
GSK3888130B Dose Level 7 IV
0
Increase to Grade 2
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Increase to Grade 3
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Clinically Significant Changes in Clinical Chemistry ResultsPrimary· 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.
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to BaselinePrimary· 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
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Erythrocytes
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
1
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
2
GSK3888130B Dose Level 6 IV
1
GSK3888130B Dose Level 7 IV
0
Glucose
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
1
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Ketones
Group
Value
95% CI
Placebo
1
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
1
Leukocytes
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Nitrite
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
1
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Protein
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
1
GSK3888130B Dose Level 7 IV
2
Specific Gravity
Group
Value
95% CI
Placebo
8
GSK3888130B Dose Level 1 IV
3
GSK3888130B Dose Level 2 IV
2
GSK3888130B Dose Level 3 SC
4
GSK3888130B Dose Level 4 IV
5
GSK3888130B Dose Level 5 SC
6
GSK3888130B Dose Level 6 IV
5
GSK3888130B Dose Level 7 IV
6
Number of Participants With Clinically Significant Changes in Vital Sign ResultsPrimary· 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.
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNAPrimary· 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)
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Cytomegalovirus DNA, Day 15
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Cytomegalovirus DNA, Day 85
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Varicella Zoster Virus DNA, Baseline (Day 1)
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Varicella Zoster Virus DNA, Day 15
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Varicella Zoster Virus DNA, Day 85
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Number of Participants With Positive Epstein-Barr Virus (EBV) DNAPrimary· 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
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
1
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
1
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
1
Baseline (Day 1), Positive >= LLQ
Group
Value
95% CI
Placebo
2
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
1
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
2
Day 15, Positive < LLQ
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
1
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
2
GSK3888130B Dose Level 7 IV
1
Day 15, Positive >= LLQ
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
1
GSK3888130B Dose Level 7 IV
0
Day 85, Positive < LLQ
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
Day 85, Positive >= LLQ
Group
Value
95% CI
Placebo
1
GSK3888130B Dose Level 1 IV
1
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
1
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
1
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) FindingsPrimary· 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
Group
Value
95% CI
Placebo
0
GSK3888130B Dose Level 1 IV
0
GSK3888130B Dose Level 2 IV
0
GSK3888130B Dose Level 3 SC
0
GSK3888130B Dose Level 4 IV
0
GSK3888130B Dose Level 5 SC
0
GSK3888130B Dose Level 6 IV
0
GSK3888130B Dose Level 7 IV
0
NOT CLINICALLY SIGNIFICANT
Group
Value
95% CI
Placebo
12
GSK3888130B Dose Level 1 IV
1
GSK3888130B Dose Level 2 IV
2
GSK3888130B Dose Level 3 SC
6
GSK3888130B Dose Level 4 IV
4
GSK3888130B Dose Level 5 SC
6
GSK3888130B Dose Level 6 IV
7
GSK3888130B Dose Level 7 IV
5
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous AdministrationSecondary· 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)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
NA
NA – NA
GSK3888130B Dose Level 2 IV
NA
NA – NA
GSK3888130B Dose Level 4 IV
NA
NA – NA
DAY 1 (15 Minutes)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
363.2
196.7 – 670.9
GSK3888130B Dose Level 2 IV
2155.9
1003.0 – 4634.4
GSK3888130B Dose Level 4 IV
15901.1
13993.4 – 18069.0
DAY 1 (30 Minutes)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
893.1
504.7 – 1580.5
GSK3888130B Dose Level 2 IV
4717.5
3173.3 – 7013.1
GSK3888130B Dose Level 4 IV
35633.0
30628.5 – 41455.2
DAY 1 (4 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
761.4
677.2 – 856.1
GSK3888130B Dose Level 2 IV
4497.0
2542.8 – 7953.0
GSK3888130B Dose Level 4 IV
32762.8
28319.4 – 37903.3
DAY 1 (8 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
753.5
483.7 – 1173.8
GSK3888130B Dose Level 2 IV
3964.2
1974.7 – 7958.0
GSK3888130B Dose Level 4 IV
31180.8
27855.3 – 34903.4
DAY 1 (12 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
758.1
601.3 – 955.8
GSK3888130B Dose Level 2 IV
3599.9
2601.7 – 4981.2
GSK3888130B Dose Level 4 IV
29821.8
26986.2 – 32955.3
DAY 1 (24 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
720.8
558.6 – 930.0
GSK3888130B Dose Level 2 IV
3781.5
2095.7 – 6823.7
GSK3888130B Dose Level 4 IV
28096.6
26173.0 – 30161.6
DAY 1 (48 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 1 IV
572.8
401.3 – 817.7
GSK3888130B Dose Level 2 IV
3184.0
2280.6 – 4445.1
GSK3888130B Dose Level 4 IV
23358.3
20418.2 – 26721.8
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous AdministrationSecondary· 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)
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
NA
NA – NA
GSK3888130B Dose Level 5 SC
NA
NA – NA
DAY 1 (4 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
NA
NA – NA
GSK3888130B Dose Level 5 SC
2540.4
1193.5 – 5407.6
DAY 1 (8 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
NA
NA – NA
GSK3888130B Dose Level 5 SC
5287.2
2659.9 – 10509.8
DAY 1 (12 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
NA
NA – NA
GSK3888130B Dose Level 5 SC
8236.8
4122.6 – 16456.5
DAY 1 (24 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
1284.2
795.2 – 2073.7
GSK3888130B Dose Level 5 SC
14161.9
7502.7 – 26731.7
DAY 1 (48 Hours)
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
2297.0
1506.7 – 3501.9
GSK3888130B Dose Level 5 SC
23239.0
12191.4 – 44297.5
DAY 6
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
3253.7
2339.4 – 4525.5
GSK3888130B Dose Level 5 SC
34612.8
25180.0 – 47579.2
DAY 8
Group
Value
95% CI
GSK3888130B Dose Level 3 SC
3327.1
2422.0 – 4570.5
GSK3888130B Dose Level 5 SC
34801.7
25828.6 – 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.
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):
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NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 26 March 2025
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.