NCT04256174

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

A Phase 1, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AK120 in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Akesobio Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a phase 1, randomized, two-part, double-blind, placebo-controlled, dose-escalation, first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of AK120 in healthy subjects (part 1, single ascending dose) and subjects with moderate- to- severe atopic dermatitis(part 2, multiple ascending dose)

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2020-02-05
• Last updated: 2022-08-17

Locations

13 sites across 2 countries: Australia, New Zealand