A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers
Hemab ApS
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
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.
Interventions
- DrugHMB-003
HMB-003 will be administered subcutaneously as a single dose
- DrugPlacebo
Placebo will be administered subcutaneously as a single dose of placebo.
Location
- Worldwide Clinical TrialsSan Antonio, Texas