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A Study of AK111 in Healthy Subjects

NCT03622021 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-02-28

No results posted yet for this study

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

Interventions

DRUG

AK111 or Placebo

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

Sponsors & Collaborators

  • Akesobio Australia Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2019-09-09
Completion
2019-09-09

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622021 on ClinicalTrials.gov