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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

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 19 Aug 2022

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At a glance

  • Drugs Manfidokimab (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; First in man
  • Sponsors Akesobio Australia

    • Most Recent Events

    • 15 Aug 2022 Status changed from recruiting to completed.
    • 15 Oct 2021 According to Akeso biopharma media release, in terms of safety, a single-dose escalation phase Ia clinical trial in healthy subjects and a multi-dose escalation phase Ib clinical trial for the treatment of atopic dermatitis of AK120 have been completed in New Zealand and Australia.
    • 27 Sep 2020 This study has been updated and divided into 2 parts (Part-1 enrols healthy subjects and part-2 involves subjects with moderate- to- severe atopic dermatitis). Study Phase has been changed from Phase 0 to phase 1, number of arms increased from 5 to 8 adding 3 more arms for Part-2 multiple ascending doses, also increasing the estimated enrolment from 40 to 70. Max. age limit increased to 65 years and inclusion, exclusion criteria for part-2 added.

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