A Study of AK111 in Healthy Subjects

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: AK111 or Placebo

• Registration Number: NCT03622021
• Lead Sponsor: Akesobio Australia Pty Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-08-04
• Study First Posted: 2018-08-09
• Study Start: 2018-08-14
• Primary Completion: 2019-09-09
• Study Completion: 2019-09-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK111 30mg	AK111 or Placebo	Single dose of 30mg AK111 or placebo is administered subcutaneously to healthy subjects
AK111 75mg	AK111 or Placebo	Single dose of 75mg AK111 or placebo is administered subcutaneously to healthy subjects
AK111 150mg	AK111 or Placebo	Single dose of 150mg AK111 or placebo is administered subcutaneously to healthy subjects
AK111 300mg	AK111 or Placebo	Single dose of 300mg AK111 or placebo is administered subcutaneously to healthy subjects
AK111 450mg	AK111 or Placebo	Single dose of 450mg AK111 or placebo is administered subcutaneously to healthy subjects
AK111 600mg	AK111 or Placebo	Single dose of 600mg AK111 or placebo is administered subcutaneously to healthy subjects

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent AE/SAEs	From baseline through 12 weeks

Secondary Outcome Measures

Name	Time	Method
Area under the concentration curve (AUC) of AK111	From baseline through 12 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs) [	From baseline through 12 weeks
Maximum observed concentration (Cmax) of AK111	From baseline through 12 weeks
The endpoint for assessment of PD including the change from baseline in serum IL-17A level and serum cytokines.	From baseline through 12 weeks

Trial Locations

Locations (1)

Christchurch Clinical Studies Trust (CCST); 🇳🇿 Christchurch, New Zealand