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

NCT07798505 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HMB-003-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this clinical study are

1. 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. 2.To measure the amount of HMB-003 in the body after injection.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment emergent adverse events (TEAEs)

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

Secondary Outcomes (3)

• Plasma concentration of HMB-003

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

• Urine concentration of HMB-003

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

• Pharmacodynamic parameter: Clot lysis

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

Study Arms (2)

HMB-003

EXPERIMENTAL

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

Drug: HMB-003

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose

Drug: Placebo

Interventions

HMB-003 DRUG

HMB-003 will be administered subcutaneously as a single dose

HMB-003

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hemab ApS: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

RECRUITING

Study Officials

• Medical Director

  Hemab

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials

CONTACT

001 888 493 8148; clinicaltrials@hemab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (1)