Adults 18 to 55, any sex, with Infections, Bacterial. 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.
Part 1: Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)Primary· Up to Day 43
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment. The number of participants with AEs and SAEs assessed in Par
Any AE
Group
Value
95% CI
GSK3342830 250 mg
5
GSK3342830 500 mg
4
GSK3342830 1000 mg
6
GSK3342830 2000 mg
5
GSK3342830 4000 mg
5
GSK3342830 6000 mg
4
Placebo, Part 1
11
Any SAE
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Part 2: Number of Participants With AE and SAEPrimary· Up to Day 56
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment. The number of participants with AEs and SAEs assessed in Par
Any AE
Group
Value
95% CI
GSK3342830 1000 mg TID
11
Placebo, Part 2
3
Any SAE
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Part 1: Number of Participants With Abnormal Hematology Parameters as a Measure of Safety-Grade 3 or HigherPrimary· Up to Day 2
Blood samples were collected and processed to measure the number of participants with abnormal platelet counts, red blood cells (RBC) count, white blood cells (WBC) count (absolute), hemoglobin, hematocrit, reticulocytes, total iron, total iron binding capacity (TIBC), ferritin, RBC indices (mean corpuscle volume \[MCV\], mean corpuscle hemoglobin \[MCH\] and mean corpuscle hemoglobin concentration \[MCHC\]) and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophil's, and basophils). Participants with abnormalities of Grade 3 or higher have been reported.
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Part 2: Number of Participants With Abnormal Hematology Parameters as a Measure of Safety-Grade 3 or HigherPrimary· Up to Day 15
Blood samples were collected and processed to measure the number of participants with abnormal platelet counts, RBC count, WBC count (absolute), hemoglobin, hematocrit, reticulocytes, total iron, TIBC, ferritin, RBC indices MCV, MCH and MCHC and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils). These were collected on Day 2, 5, 10 and Day 15, during Part 2 of the study. Part 2 is repeat dose escalation. Participants with abnormalities of Grade 3 or higher have been reported.
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Part 1: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or HigherPrimary· Day 2
Blood samples were collected and processed to measure the number of participants with abnormal blood urea nitrogen (BUN), creatinine, glucose, bicarbonate, sodium, potassium, chloride, calcium, aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP) levels, uric acid, total and direct bilirubin, total protein and albumin. These were collected on Day 1, during Part 1(single dose escalation) of the study. Participants with abnormalities Grade 3 or higher were reported.
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or HigherPrimary· Up to Day 15
Blood samples were collected and processed to measure the number of participants with abnormal BUN, creat, glucose, bicarbonate, sodium, potassium, chloride, calcium, AST/SGOT, ALT/SGPT, ALP levels, uric acid, total and direct bilirubin, total protein and albumin. These were collected on Day 2, 5, 10 and Day 15 during Part 2 (repeat dose escalation), of the study. Participants with abnormalities Grade 3 or higher were reported.
Serum Glucose
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
0
Serum or Plasma ALT
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
0
Serum or Plasma albumin
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
0
Serum or Plasma ALP
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Serum or Plasma AST
Group
Value
95% CI
GSK3342830 1000 mg TID
2
Placebo, Part 2
0
Serum or Plasma Calcium
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Serum or Plasma Chloride
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Serum or Plasma Creat
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Part 1: Number of Participants Having Abnormal Urine Parameters (Using Dipstick Test) as a Measure of SafetyPrimary· Up to Day 2
An aliquot of the urine samples from first morning void urine samples was collected to analyze specific gravity, pH, glucose, protein, blood and ketone bodies by dipstick method, microscopic examination (if blood or protein is abnormal), albumin to creatinine ration (ACR), neutrophil gelatinase associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1). Urine samples were analyzed after the end of the study to verify if a clinical signal is detected. Urine samples were collected on Day 1 of Part 1 (Single-dose escalation) of the study.
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Part 2: Number of Participants Having Abnormal Urine Parameters (Using Dipstick Test) as a Measure of SafetyPrimary· Day 2, 5, 10 and Day 15
An aliquot of the urine samples from first morning void urine samples was collected to analyze specific gravity, pH, glucose, protein, blood and ketone bodies by dipstick method, microscopic examination (if blood or protein is abnormal), ACR, NGAL and KIM-1. These urine samples were analyzed after the end of the study to verify if a clinical signal is detected. The samples were collected on Day 2, 5, 10, and Day 15 of Part 2 (Repeat dose escalation) of the study.
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI)Primary· Up to Day 3
Triplicate 12-lead ECGs were obtained at least 5 minutes apart within 1 hr before dosing. Single ECGs were obtained at all other time points on Day 1 at 0.5 hr, 1 hr, 1.5 hr, 2, 3, 4, 6, 12 and 24 hr, Day 2 (36 hr) and Day 3 (48 hr) during Part 1 (single dose escalation phase) of the study. All the 12-lead ECGs were measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Heart Rate
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
PR Interval
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
1
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
QRS Duration
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
1
GSK3342830 2000 mg
3
GSK3342830 4000 mg
1
GSK3342830 6000 mg
1
Placebo, Part 1
2
QT Interval
Group
Value
95% CI
GSK3342830 250 mg
1
GSK3342830 500 mg
2
GSK3342830 1000 mg
1
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
1
Placebo, Part 1
2
QTc (Bazett)
Group
Value
95% CI
GSK3342830 250 mg
1
GSK3342830 500 mg
1
GSK3342830 1000 mg
1
GSK3342830 2000 mg
1
GSK3342830 4000 mg
2
GSK3342830 6000 mg
2
Placebo, Part 1
3
QTc (Fridericia)
Group
Value
95% CI
GSK3342830 250 mg
1
GSK3342830 500 mg
0
GSK3342830 1000 mg
1
GSK3342830 2000 mg
0
GSK3342830 4000 mg
1
GSK3342830 6000 mg
0
Placebo, Part 1
1
RR Interval
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Part 2: Number of Participants With ECG Parameters of PCIPrimary· Up to Day 16
Triplicate 12-lead ECGs were obtained at least 5 minutes apart within 1 hr before the start of infusion (pre-dose) on Day 1. Single ECGs were obtained at 0.5, 1, 1.5, 2, 3, 4, 6, and 12 hrs after the start of infusion on Day 1 and Day 15, within 1 hr before the start of the morning infusion on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and in the morning on Day 16. All the 12-lead ECGs were measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Heart Rate
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
PR Interval
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
0
QRS Duration
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
QT Interval
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
2
QTc (Bazett)
Group
Value
95% CI
GSK3342830 1000 mg TID
2
Placebo, Part 2
1
QTc (Fridericia)
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
1
RR Interval
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI)Primary· Up to Day 3
The vital sign includes systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature which were measured in a semi-supine position, where the participant had rested in the same position for at least 5 minutes. The number of participants with vital values, of PCI were reported. These were collected on Day 1 at pre-dose, 0.5 hr, 1 hr, 1.5 hr, 2, 3, 4, 6, 12 and 24 hr, Day 2 (36 hr) and Day 3 (48 hr) during Part 1 (single dose escalation phase) of the study.
Systolic Blood Pressure
Group
Value
95% CI
GSK3342830 250 mg
1
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
1
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
1
Diastolic Blood Pressue
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
1
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
1
Pulse rate
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
1
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Temperature
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Respiratory rate
Group
Value
95% CI
GSK3342830 250 mg
0
GSK3342830 500 mg
0
GSK3342830 1000 mg
0
GSK3342830 2000 mg
0
GSK3342830 4000 mg
0
GSK3342830 6000 mg
0
Placebo, Part 1
0
Part 2: Number of Participants With Vital Signs of PCIPrimary· Up to Day 16
The vitals for systolic, diastolic blood pressure, heart rate, respiratory rate and temperature were taken in a semi-supine position, where the participant had rested in the same position for atleast 5 minutes. The number of participants with vital values, of PCI were reported. These were collected from Day 1 to Day 16. Assessments were done within 1 hr before the start of infusion (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 12 hrs after the start of infusion on Days 1 and 15, within 1 hr before the start of the morning infusion and on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, an
SBP
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
DBP
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
1
Pulse rate
Group
Value
95% CI
GSK3342830 1000 mg TID
1
Placebo, Part 2
0
Temperature
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Respiratory rate
Group
Value
95% CI
GSK3342830 1000 mg TID
0
Placebo, Part 2
0
Adverse events — posted to ClinicalTrials.gov
Time frame: SAEs and AEs were collected from start of study treatment (Day 1) up to Day 56.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled, dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3342830 after administration of single intravenous (IV) infusion in Part 1 and repeat IV infusion in Part 2 in healthy subjects. Part 1 will investigate escalating single IV doses of GSK3342830. Part 2, will investigate escalating repeat IV doses of GSK3342830 with repeat dosing for 15 days as follows: a single IV infusion on Day 1, TID (three times a day) IV infusions on Days 2 through 14 (approximately every 8 hours), and a single IV infusion on Day 15. The planned starting GSK3342830 dose in Part 1 is 250 milligram (mg) administered as a single IV infusion. The dose is planned to increase in subsequent cohorts to 500, 1000, 2000, 4000, and less than or equal to (≤) 6000 mg. Part 1 will be divided into 6 cohorts (A-F) and each cohort will enroll 10 subjects (6 in active and 2 in placebo). Dose escalation will be conducted only if it is supported by the preliminary safety, tolerability, and PK results from the preceding dose levels in the study. The repeat dose escalation component (Part 2) of this study will be planned to be initiated after completion and evaluation of the all single dose cohorts up to and including 4000 mg.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 12 September 2018
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/NCT02751424.