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

NCT05324293 | Completed Phase 1 FDA Drug

• 1 other identifier: HMI-115102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• TAHC(target area hair count) of non-vellus

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

  From baseline to Week 24

Secondary Outcomes (5)

• TAHC of non-vellus

  From baseline to Week 6, 12, 18, and 36

• TAHW(target area hair width) of non-vellus hair

  From baseline to Week 6, 12, 18, 24, and 36

• Investigator Global Assessment (IGA)

  Week 6, 12, 18, 24, and 36

• Subject self-Assessment (SSA)

  Week 6, 12, 18, 24, and 36

• Hair growth questionnaire assessment (HGQA)

  Week 6, 12, 18, 24, and 36

Study Arms (1)

HMI-115 240mg

EXPERIMENTAL

Drug: HMI-115

Interventions

HMI-115 DRUG

Once Every 2 weeks, subcutaneously injection

HMI-115 240mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hope Medicine (Nanjing) Co., Ltd: lead

Study Sites (1)

Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology

Melbourne E., Victoria, Australia

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 12, 2022
• Study Start: May 11, 2022
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-10

Locations

AU (1)