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RecruitingNCT07798505Updated Sep 10, 2026

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

A Phase 1 interventional study of HMB-003 and Placebo in Healthy Adult Participants, sponsored by Hemab ApS. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Hemab ApS · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Healthy Adult Participants
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    HMB-003

    Participants will be administered a single dose of HMB-003 at an escalating dose level according to the assigned cohort.

    Drug: HMB-003

  • Placebo comparator
    Placebo

    Participants will be administered a single dose

    Drug: Placebo

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.

05

What researchers measure

Primary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs)

    Time frame: From Day 1 up to 42 days after a single dose of study drug on Day 1

Secondary outcomes

  1. Plasma concentration of HMB-003

    Time frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1

  2. Urine concentration of HMB-003

    Time frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1

  3. Pharmacodynamic parameter: Clot lysis

    Time frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1

06

Study locations

1 of 1 sites recruiting
  • Worldwide Clinical Trials
    San Antonio, Texas 78217, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07798505
Lead sponsor
Hemab ApS
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Aug 17, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Clinical Trials
Contact
clinicaltrials@hemab.com
001 888 493 8148
Medical Director
study director · Hemab

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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