NCT04256174 - A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 15, 2020

Primary Completion Date

October 29, 2021

Study Completion Date

October 29, 2021

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.

Trial Locations (13)

2019

Emeritus Sydney, Botany

2031

Scientia Clinical Research Ltd, Randwick

3110

P3 Research Tauranga, Tauranga

3145

Emeritus Melbourne, Camberwell

4130

P3 Research Hawkes Bay, Havelock North

6021

P3 Research Wellington, Wellington

8011

Christchurch Clinical Studies Trust, Christchurch

8013

Southern Clinical Trials - Christchurch, Christchurch

Unknown

CMAX Clinical Research, Adelaide

Sinclair Dermatology, East Melbourne

Peninsula Specialist Centre, Kippa-Ring

Optimal Clinical Trials, Auckland

0626

Southern Clinical Trials - Waitemata, Birkenhead

All Listed Sponsors

lead

Akesobio Australia Pty Ltd

INDUSTRY