NCT03622021

A Study of AK111 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose-Escalation First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK111 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Akesobio Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	AK111 or Placebo	All the subjects in each cohort will be randomized in a 3:1 ratio to receive either AK111 or Placebo.

Timeline

• Start date: 2018-08-14
• Primary completion: 2019-09-09
• Completion: 2019-09-09
• First posted: 2018-08-09
• Last updated: 2025-02-28

Locations

1 site across 1 country: New Zealand