Trial results for a Phase 1 pharmacokinetic study of depemokimab in healthy Chinese participants were posted on ClinicalTrials.gov on 2026-05-26. The study investigated the pharmacokinetics, safety, tolerability, and immunogenicity of two subcutaneous dose levels, 100mg and 300mg, showing higher exposure with the higher dose.
Background
Depemokimab (also known as exdensur) is a drug being investigated, with Asthma listed as a condition of interest for its development. This particular study focused on understanding how the drug behaves in the body of healthy individuals.
Trial design
The completed Phase 1 study (NCT05140200) enrolled 20 healthy Chinese participants. The study's primary objective was to investigate the pharmacokinetics (PK), safety, tolerability, and immunogenicity of two dose levels of depemokimab administered subcutaneously. Participants received either a 100mg or 300mg single subcutaneous dose of depemokimab.
Key results
The trial reported pharmacokinetic measurements, specifically the Area Under the Plasma Concentration-Time Curve (AUC) for depemokimab at two dose levels:
- Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) for Depemokimab 100mg: geometric mean of 1685.946 day*micrograms per millilitres.
- Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) for Depemokimab 300mg: geometric mean of 5224.107 day*micrograms per millilitres.
- AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) for Depemokimab 100mg: geometric mean of 1472.963 day*micrograms per millilitres.
- AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) for Depemokimab 300mg: geometric mean of 4604.879 day*micrograms per millilitres.
- AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) for Depemokimab 100mg: geometric mean of 414.467 day*micrograms per millilitres.
- AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) for Depemokimab 300mg: geometric mean of 1357.843 day*micrograms per millilitres.
- Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) for Depemokimab 100mg: geometric mean of 12.381 Percentage of AUCex.
- Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) for Depemokimab 300mg: geometric mean of 11.611 Percentage of AUCex.
What this means
The pharmacokinetic results from this Phase 1 study indicate that depemokimab exhibits dose-dependent exposure in healthy Chinese participants. The geometric mean AUC values were notably higher for the 300mg dose compared to the 100mg dose across various time intervals, which is an expected finding for a drug in early development. For instance, the geometric mean AUC(0-Infinity) was 1685.946 day*micrograms per millilitres for the 100mg dose and 5224.107 day*micrograms per millilitres for the 300mg dose. These findings provide crucial data for informing dose selection and design of subsequent clinical trials for depemokimab.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05140200, titled "Study of GSK3511294 in Healthy Chinese Participants", were posted on 2026-05-26 on clinicaltrials.gov.