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

September 9, 2026 updated by: Hemab ApS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Worldwide Clinical Trials
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will be administered a single dose
Drug: Placebo
Placebo will be administered subcutaneously as a single dose of placebo.
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
HMB-003 will be administered subcutaneously as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From Day 1 up to 42 days after a single dose of study drug on Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of HMB-003
Time Frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
From 0 hours (pre-dose) to 42 days after a single dose on Day 1
Urine concentration of HMB-003
Time Frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
From 0 hours (pre-dose) to 42 days after a single dose on Day 1
Pharmacodynamic parameter: Clot lysis
Time Frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
From 0 hours (pre-dose) to 42 days after a single dose on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hemab ApS

Investigators

  • Study Director: Medical Director, Hemab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HMB-003-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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