drugset / Trial / NCT03622021
A Study of AK111 in Healthy Subjects
RandomizedParallel-groupTriple-blindOther
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single dose-escalation first-in human study to evaluate the safety, tolerability, PK, PD and immunogenicity of AK111 in healthy subjects following SC administration. The study will consist of cohorts of healthy subjects. Cohort 1, four unique subjects will be randomized to receive either active AK111 (N=3) or matching placebo (N=1). Cohorts 2, 3, 4 and 5, eight unique subjects will be randomized to receive either active AK111 (N=6) or matching placebo (N=2). Approximately 36 subjects will be treated in this study.
Timeline
- Start
- 2018-08-14
- Primary completion
- 2019-09-09
- Completion
- 2019-09-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GUMOKIMAB | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | GUMOKIMAB | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | GUMOKIMAB | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | GUMOKIMAB | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | GUMOKIMAB | Monoclonal antibody | 450 mg | Subcutaneous |
| Subject | GUMOKIMAB | Monoclonal antibody | 600 mg | Subcutaneous |