Healthy Adult Participants
Conditions
Brief 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.
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.
Sponsors
Hemab ApS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | From Day 1 up to 42 days after a single dose of study drug on Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of HMB-003 | From 0 hours (pre-dose) to 42 days after a single dose on Day 1 |
| Urine concentration of HMB-003 | From 0 hours (pre-dose) to 42 days after a single dose on Day 1 |
| Pharmacodynamic parameter: Clot lysis | From 0 hours (pre-dose) to 42 days after a single dose on Day 1 |
Countries
United States
Contacts
CONTACTClinical Trials
STUDY_DIRECTORMedical Director
Hemab
Outcome results
None listed