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NCT Number: NCT07798505

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

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.

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HMB-003

Drug

HMB-003 will be administered subcutaneously as a single dose

Placebo

Drug

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

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hemab ApS

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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