A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis

Summary

A dose escalation, first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of AK120 in healthy subjects and subjects with moderate- to- severe atopic dermatitis

Conditions

• Atopic Dermatitis

Interventions

DRUG

AK120 or placebo- Part 1- Cohort 1

Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects

DRUG

AK120 or placebo- Part 1- Cohort 2

Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects

DRUG

AK120 or placebo- Part 1- Cohort 3

Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects

DRUG

AK120 or placebo- Part 1- Cohort 4

Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects

DRUG

AK120 or placebo- Part 1- Cohort 5

Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects

DRUG

AK120 or placebo- Part 2- Cohort 1

Multiple low doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis

DRUG

AK120 or placebo- Part 2- Cohort 2

Multiple medium doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis

DRUG

AK120 or placebo- Part 2- Cohort 3

Multiple high doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis

DRUG

AK120 or placebo- Part 2- Cohort 4

Multiple high doses of AK120 or placebo are administered subcutaneously as a bi-weekly dose for a total of three doses to subjects with moderate-to-severe atopic dermatitis.

Sponsors & Collaborators

• Akesobio Australia Pty Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-15

Primary Completion

2021-10-29

Completion

2021-10-29

Countries

• Australia
• New Zealand

Study Locations