Phase 1
N=20
Study of GSK3511294 in Healthy Chinese Participants
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT05140200 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab — 1685.946; 5224.107 day*micrograms per millilitres
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Depemokimab (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab |
1685.946; 5224.107 | — |
| PRIMARY AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab |
1472.963; 4604.879 | — |
| PRIMARY AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab |
414.467; 1357.843 | — |
| PRIMARY AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab |
1027.083; 3255.132 | — |
| PRIMARY AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab |
1472.912; 4605.772 | — |
| PRIMARY Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab |
12.381; 11.611 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Depemokimab |
16.82; 55.04 | — |
| PRIMARY Time of Occurrence of Cmax (Tmax) Of Depemokimab |
13.960; 13.980 | — |
| PRIMARY Time To Last Quantifiable Concentration (Tlast) of Depemokimab |
181.980; 181.980 | — |
| PRIMARY Apparent Clearance (CL/F) of Depemokimab |
0.0593; 0.0574 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Depemokimab |
5.033; 4.827 | — |
| PRIMARY Terminal Elimination Rate Constant (Lambda Z) of Depemokimab |
0.0118; 0.0119 | — |
| PRIMARY Terminal Phase Half-Life (T1/2) of Depemokimab |
58.827; 58.246 | — |
| SECONDARY Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs) |
10; 10; 0; 0 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes |
-0.000; -0.007; -0.006; -0.002; -0.005; -0.002 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Hemoglobin |
-3.5; -2.1; -1.0; -5.2; -3.6; -6.2 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Hematocrit |
-0.0112; -0.0191; -0.0077; -0.0231; -0.0136; -0.0170 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) |
-0.75; -0.23; 1.41; 0.60; -0.22; 0.26 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) |
-0.01; 0.81; 0.86; 0.72; 0.20; -0.04 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Reticulocytes |
-0.052; 0.085; 0.601; 0.162; 0.083; 0.046 | — |
| SECONDARY Change From Baseline In Hematology Parameter: Erythrocytes |
-0.083; -0.197; -0.160; -0.289; -0.138; -0.205 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea |
1.1; 0.9; -0.3; 0.1; 0.3; 0.9 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine |
-0.62; 0.17; -0.30; -0.28; -0.77; 0.74 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) |
-1.7; -1.9; 0.7; 1.3; 0.9; -2.7 | — |
| SECONDARY Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein |
-1.13; -1.62; -0.89; -0.83; -0.03; -0.57 | — |
| SECONDARY Absolute Values of Complement C3 And C4 at Each Timepoint |
0.876; 0.913; 0.836; 0.899; 0.867; 0.840 | — |
| SECONDARY Ratio to Baseline at Each Timepoint of Complement C3 And C4 |
0.954; 0.984; 0.989; 0.919; 1.013; 0.981 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure |
-4.48; 0.34; 1.22; 2.54; 1.72; 1.34 | — |
| SECONDARY Change From Baseline in Body Temperature |
0.07; 0.19; 0.21; 0.44; -0.05; 0.12 | — |
| SECONDARY Change From Baseline in Pulse Rate |
-5.96; 2.13; -4.16; 1.63; 7.24; 9.53 | — |
| SECONDARY Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate |
-0.84; -2.64; -2.27; -3.65; 4.53; -0.46 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Titres of Binding ADA's to Depemokimab |
— | — |
Summary
This single dose pharmacokinetic (PK) study aims to investigate the PK, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants
Eligibility Criteria
Inclusion Criteria
- Participant between 18 to 45 years of age.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs.
- Body weight greater than or equal to (>=)50.0 kilograms (kg) for males, >=45.0 kg for females, and body mass index (BMI) within the range (19.0-26.0) kg/meter square (m^2) (inclusive).
- Contraceptive use by men and/or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent.
Exclusion Criteria
- Participant is pregnant, breastfeeding, or a woman of childbearing potential
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe allergic reactions/intolerance
- Current evidence or recent history of an infective illness
- A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
- Clinically significant abnormalities
- Participants with Coronavirus Disease-2019 (COVID-19)
- With prior/concurrent clinical study experience.
Data sourced from ClinicalTrials.gov (NCT05140200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.