HVPhase 1NCT07584876
A Phase 1 Clinical Study in Healthy Participants
A Phase 1 study of HV, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 1 site in Australia.
Trial summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HV
- 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 siteAustralia
- Study dates
- 29 May 2026to 31 Jan 2028
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have given written informed consent and be able to comply with all study requirements
- Males or females aged 18 to 65 years old, inclusive, at the time of informed consent
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.
- APTT, PT, INR, and FXI activity within the normal range at screening
- Agree to avoid activities that can increase the risk of severe bleeding
- Female participants must be non-pregnant
- Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 360 days following administration of the study drug
Who cannot join
- Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters
- Any skin condition and/or tattoo
- Hospitalization for any reason within 60 days prior to screening
- History or presence of cancer
- Any clinically significant acute condition
- Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting
Show all 17Show fewer
- Clinical laboratory findings outside of range
- Any liver function panel analyte value > 1.2 × upper limits of normal (ULN)
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
- Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
- Use of an investigational agent
- .Used of prescription drugs
- History or clinical evidence of alcohol substance abuse
- History or clinical evidence of drug abuse
- Positive test for alcohol or drugs of abuse at screening or Day -1
- Donated or lost >200 mL of blood
- .Any conditions which, in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Argo Investigative Site
Perth, Western Australia
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of BW-41012 when administered subcutaneously to healthy participants. Approximately 40 men and women aged ≥18 to ≤65 years (inclusive) who fulfill the inclusion and exclusion criteria will be enrolled in 5 cohorts.
- Conditions
- HV
- Being tested
- BW-41012 injection or Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BW-41012 injection or PlaceboDrug
BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or PlaceboDrug
BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or PlaceboDrug
BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or PlaceboDrug
BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or PlaceboDrug
BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BW-41012 (cohort 1, n=8) Receives: Drug: BW-41012 injection or Placebo |
| Cohort 2 | Experimental | BW-41012 (cohort 2, n=8) Receives: Drug: BW-41012 injection or Placebo |
| Cohort 3 | Experimental | BW-41012 (cohort 3, n=8) Receives: Drug: BW-41012 injection or Placebo |
| Cohort 4 | Experimental | BW-41012 (cohort 4, n=8) Receives: Drug: BW-41012 injection or Placebo |
| Cohort 5 | Experimental | BW-41012 (cohort 5, n=8) Receives: Drug: BW-41012 injection or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests
Measured: up to 24 hours
Secondary outcomes (2)
Secondary endpoints
Assessment the PK parameters change
- Maximum observed plasma concentration (Cmax)
- Time to maximum plasma concentration (Tmax)
- Terminal elimination half-life (t1/2)
- Area under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUClast)
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Measured: up to 8 days
Secondary endpoints
Assessment the PD parameters change
- Change from baseline in the level of factor XI
- Change from baseline in the level of activated partial thromboplastin time
Measured: up to 360days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start29 May 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HVStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584876
- Sponsor's protocol ID
- BW-41012-1001
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07584876
- Acronym / sponsor ID
- BW-41012-1001
- Conditions
- HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 May 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.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
Detailed description
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of BW-41012 when administered subcutaneously to healthy participants. Approximately 40 men and women aged ≥18 to ≤65 years (inclusive) who fulfill the inclusion and exclusion criteria will be enrolled in 5 cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BW-41012 injection or PlaceboBW-41012 (cohort 1, n=8) |
| Cohort 2 | Experimental | Drug: BW-41012 injection or PlaceboBW-41012 (cohort 2, n=8) |
| Cohort 3 | Experimental | Drug: BW-41012 injection or PlaceboBW-41012 (cohort 3, n=8) |
| Cohort 4 | Experimental | Drug: BW-41012 injection or PlaceboBW-41012 (cohort 4, n=8) |
| Cohort 5 | Experimental | Drug: BW-41012 injection or PlaceboBW-41012 (cohort 5, n=8) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have given written informed consent and be able to comply with all study requirements
- Males or females aged 18 to 65 years old, inclusive, at the time of informed consent
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.
- APTT, PT, INR, and FXI activity within the normal range at screening
- Agree to avoid activities that can increase the risk of severe bleeding
Key exclusion criteria (17 listed)
- Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters
- Any skin condition and/or tattoo
- Hospitalization for any reason within 60 days prior to screening
- History or presence of cancer
- Any clinically significant acute condition
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 |
|---|---|---|
| BW-41012 injection or PlaceboBW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection | Drug | Cohort 1 |
| BW-41012 injection or PlaceboBW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection | Drug | Cohort 2 |
| BW-41012 injection or PlaceboBW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection | Drug | Cohort 3 |
| BW-41012 injection or PlaceboBW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection | Drug | Cohort 4 |
| BW-41012 injection or PlaceboBW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection | Drug | Cohort 5 |
Primary outcome
Primary endpoints
Time frame: up to 24 hours
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests
2 secondary outcomes
Secondary endpoints
Time frame: up to 8 days
Secondary endpoints
Time frame: up to 360days
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 of HV, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 1 site in Australia.
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 7 inclusion and 17 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 9 Jul 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 Australia. 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. 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 Ying Zhang (+8618806137286, yingzhang@argobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints (time frame: up to 24 hours). 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 9 Jul 2026.