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Clinical Trials/ACTRN12622000680763
ACTRN12622000680763
Completed
Phase 1

To evaluate the safety, tolerability and efficacy in male and female with androgenetic alopecia treated with HMI-115 over a 24-week treatment period

Hope Medicine (Nanjing) Co., Ltd0 sites16 target enrollmentMay 11, 2022
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Hope Medicine (Nanjing) Co., Ltd
Enrollment
16
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 11, 2022
End Date
September 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hope Medicine (Nanjing) Co., Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. 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.
  • •2\. Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
  • •3\. 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

  • •1\. Subject with clinical diagnosis of non\-AGA (Androgenetic Alopecia\_
  • •2\. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
  • •3\. Subject has used therapies associated with hair growth or therapy with confirmed effects on PRL level, within defined time window before screening.
  • •4\. Subject with history of another pituitary, posterior pituitary, or hyperthyroidism
  • •5\. Subject has clinically significantly abnormal laboratory tests at Screening
  • •6\. Known hypersensitivity to any of the IMP (Investigational Medicinal Product) ingredients
  • •7\. Any other conditions in the investigator's opinion that prevent the subject from participating

Outcomes

Primary Outcomes

Not specified

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