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
Overview
- Phase
- Phase 1
- Intervention
- AK111 or Placebo
- Conditions
- Psoriasis
- Sponsor
- Akesobio Australia Pty Ltd
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Incidence of treatment emergent AE/SAEs
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AK111 30mg
Single dose of 30mg AK111 or placebo is administered subcutaneously to healthy subjects
Intervention: AK111 or Placebo
AK111 75mg
Single dose of 75mg AK111 or placebo is administered subcutaneously to healthy subjects
Intervention: AK111 or Placebo
AK111 150mg
Single dose of 150mg AK111 or placebo is administered subcutaneously to healthy subjects
Intervention: AK111 or Placebo
AK111 300mg
Single dose of 300mg AK111 or placebo is administered subcutaneously to healthy subjects
Intervention: AK111 or Placebo
AK111 450mg
Single dose of 450mg AK111 or placebo is administered subcutaneously to healthy subjects
Intervention: AK111 or Placebo
AK111 600mg
Single dose of 600mg AK111 or placebo is administered subcutaneously to healthy subjects
Intervention: AK111 or Placebo
Outcomes
Primary Outcomes
Incidence of treatment emergent AE/SAEs
Time Frame: From baseline through 12 weeks
Secondary Outcomes
- 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)