Healthy Adult ParticipantsPhase 1NCT07798505
A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers
A Phase 1 study testing HMB-003 in people with Healthy Adult Participants, run by Hemab ApS at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- HMB-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Worldwide Clinical Trials
San Antonio, Texas, 78217
Worldwide Clinical Trials, 210-635-1515, participate@worldwide.com
About this study
The purposes of this clinical study are
- To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, and if there are any important side effects.
- To measure the amount of HMB-003 in the body after injection.
- Conditions
- Healthy Adult Participants
- Being tested
- HMB-003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB-003Drug
HMB-003 will be administered subcutaneously as a single dose
PlaceboDrug
Placebo will be administered subcutaneously as a single dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| HMB-003 | Experimental | Participants will be administered a single dose of HMB-003 at an escalating dose level according to the assigned cohort. Receives: Drug: HMB-003 |
| Placebo | Placebo comparator | Participants will be administered a single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAEs)
Measured: 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
Measured: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
Urine concentration of HMB-003
Measured: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
Pharmacodynamic parameter: Clot lysis
Measured: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start17 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemab ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Hemab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798505
- Sponsor's protocol ID
- HMB-003-101
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07798505
- Acronym / sponsor ID
- HMB-003-101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hemab ApSIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this clinical study are
- To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, and if there are any important side effects.
- To measure the amount of HMB-003 in the body after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB-003 | Experimental | Drug: HMB-003Participants will be administered a single dose of HMB-003 at an escalating dose level according to the assigned cohort. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMB-003HMB-003 will be administered subcutaneously as a single dose | Drug | HMB-003 |
| PlaceboPlacebo will be administered subcutaneously as a single dose of placebo. | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Plasma concentration of HMB-003
Time frame: 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
Pharmacodynamic parameter: Clot lysis
Time frame: From 0 hours (pre-dose) to 42 days after a single dose on Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Hemab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMB-003 in people with Healthy Adult Participants, run by Hemab ApS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (001 888 493 8148, clinicaltrials@hemab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.