Recruiting
Phase 1

HMB-003

Sponsor:

Hemab ApS

Code:

NCT07798505

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

HMB-003

Placebo

Study Details

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.

Conditions

Healthy Adult Participants

Study ID

NCT07798505

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HMB-003

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

placebo comparator: Placebo

Participants will be administered a single dose

Interventions

HMB-003

HMB-003 will be administered subcutaneously as a single dose

Placebo

Placebo will be administered subcutaneously as a single dose of placebo.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials

001 888 493 8148clinicaltrials@hemab.com

Locations

Worldwide Clinical Trials

Recruiting

San Antonio, Texas, United States, 78217

Contacts

Worldwide Clinical Trials

210-635-1515participate@worldwide.com

More Information

Sponsor

Hemab ApS

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Hemab ApS on 2026-09-10.