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

ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHemab ApS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: HMB-003Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hemab ApS

Lead sponsor

Source ClinicalTrials.gov
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