A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers

The purposes of this clinical study are 1. To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, and if there are any important side effects. 2. To measure the amount of HMB-003 in the body after injection.

CT.gov Identifier
NCT07798505
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Hemab Therapeutics
Collaborator
N/A
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Alport syndrome
Study Drug
HMB-003
Genes
COL4A4
COL4A3
Study Dates
Sep 2026 - Apr 2027
Sex
Female & Male
Age
18 - 50 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • * Participant is aged 18 to 50 years, inclusive, at the time of signing informed consent.
  • * Overall healthy as determined by medical evaluation including physical examination, vital signs, laboratory tests, and ECG.
Exclusion Criteria:
  • Participant has a history of clinically significant hypersensitivity to any excipients of the study drug
  • * Participant is pregnant, breastfeeding, or <6 weeks postpartum.
  • * Participant has received investigational drug or device in another clinical study within 30 days or 5 half-lives, whichever is longer, before dosing.

Protocol Summary

The purposes of this clinical study are

1. To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, and if there are any important side effects.

2. To measure the amount of HMB-003 in the body after injection.

Study Locations

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