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OpenTrials
Completed

NCT Number: NCT05324293

To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period

An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology

Melbourne E., Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
  • Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.

Exclusion criteria

  • Subject with clinical diagnosis of non-AGA
  • Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
  • Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
  • Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
  • Subject has clinically significantly abnormal laboratory tests at Screening
  • Known hypersensitivity to any of the IMP ingredients
  • Any other conditions in the investigator's opinion that prevent the subject from participating

Treatment and study plan

HMI-115

Drug

Once Every 2 weeks, subcutaneously injection

Primary outcomes

  1. TAHC(target area hair count) of non-vellus

    Time frame: From baseline to Week 24

    Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.

Secondary outcomes

  1. TAHC of non-vellus

    Time frame: From baseline to Week 6, 12, 18, and 36

    Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.

  2. TAHW(target area hair width) of non-vellus hair

    Time frame: From baseline to Week 6, 12, 18, 24, and 36

    Change in target area hair width (TAHW) of non-vellus hair from baseline to Week 6, 12, 18, 24, and 36 in male and female, respectively.

  3. Investigator Global Assessment (IGA)

    Time frame: Week 6, 12, 18, 24, and 36

    IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

  4. Subject self-Assessment (SSA)

    Time frame: Week 6, 12, 18, 24, and 36

    SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

  5. Hair growth questionnaire assessment (HGQA)

    Time frame: Week 6, 12, 18, 24, and 36

    HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

Sponsors and collaborators

Lead sponsor

Hope Medicine (Nanjing) Co., Ltd

Industry

Registry information

Official study title

An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female with Androgenetic Alopecia Treated with HMI-115 Over a 24-Week Treatment Period

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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