drugset / Trial / NCT03622021

A Study of AK111 in Healthy Subjects

NCT03622021 ↗

Phase 1 Completed 68 enrolled Akeso Biopharma, Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications