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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Hemab ApS
Study ID
NCT07798505
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Aug 17, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Worldwide Clinical TrialsSan AntonioTexas78217
Worldwide Clinical Trials
[email protected]
210-635-1515

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By research site
Worldwide Clinical Trials· San Antonio, TX

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