Safety and how the body handles HMB-003 in healthy adults
Official title: A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers
Run by Hemab ApS · NCT07798505 · Data updated 2026-11-12
A first-in-human test to see if HMB-003 is safe in healthy adults and how it behaves in the body compared with a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Hemab ApS Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Status | Recruiting |
| Started | August 17, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07798505 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–50 without significant medical conditions or drug hypersensitivities who pass screening evaluations.
✕Probably not a fit
Participants with significant medical issues, pregnancy, recent use of investigational products, or known hypersensitivity to any excipients may not benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study will enroll healthy adults aged 18 to 50 to receive HMB-003 or placebo. Researchers will monitor tolerability, side effects, and collect pharmacokinetic data to understand how the drug is absorbed, distributed, metabolized, and eliminated. The trial will help determine initial safety signals and dosing considerations for future studies. Participation requires medical screening, adherence to the protocol, and avoidance of other investigational products during the study window. The lead sponsor is Hemab ApS, with sites at Worldwide Clinical Trials in San Antonio, TX, and no listed collaborators.
Why it matters
Potential benefit: If successful, participants may experience no direct benefit, but findings could advance the development of HMB-003 for future use.
How similar studies have gone: First-in-human studies of similar agents typically establish safety and pharmacokinetics, but specific outcomes for HMB-003 are not yet known.
Who can join: the full rules
Show full inclusion / 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.
Where it's running
-
Worldwide Clinical Trials
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Clinical Trials
- Email: clinicaltrials@hemab.com
- Phone: 001 888 493 8148
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.