HVPhase 1HVNCT07528053
A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants
A Phase 1 study testing BW-20805 and BW-20805-2 in people with HV, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 1 site in Australia.
Trial summary
A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HV
- What is being tested?
- BW-20805 and BW-20805-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Apr 2026to 5 Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- 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 60 years old, inclusive, at the time of informed consent.
- Body mass index (BMI) ≥18 and ≤32 kg/m2 and body weight ≥50 kg 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 48 weeks following administration of the study drug
Who cannot join
- Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that
- Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site
- Hospitalization for any reason within 60 days prior to screening.
- Presence of carcinoma and history of carcinoma
- 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 22Show fewer
- Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening
- Participants with ANY in clinical laboratory tests at screening or Day-1.
- History of bleeding diathesis or clinically significant hemorrhagic disorders Positive for hepatitis B surface antigen
- Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
- Use of an investigation agent or device within 30 days or 5 half-lives (whichever is longer) before the study drug administration.
- Used prescription drugs, excluding hormonal contraceptives
- Used over-the-counter (OTC) medications
- Have received treatment with small interfering RNA (siRNA) within the last 12 months
- History of allergic reactions to synthetic siRNA or GalNAc and/or any other clinically significant allergic reactions.
- Use of more than 10 tobacco/nicotine containing products or equivalent per day within 30 days prior to screening and not willing to abstain for 48 hours prior to admission to the unit
- History or clinical evidence of alcohol substance abuse, within the 12 months before screening
- History or clinical evidence of drug abuse, within the 12 months before screening
- Positive test for alcohol or drugs of abuse at screening or Day -1
- Have received vaccination with a live vaccine
- Donated or lost >200 mL of blood or plasma within 30 days prior to screening
- 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.
About this study
Official title: A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants
Read the detailed description
A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
- Conditions
- HV
- Being tested
- BW-20805, BW-20805-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BW-20805Drug
Cohort 1 will receive SC administrations of BW-20805 on Day1.
BW-20805Drug
Group 2 will receive SC administrations of BW-20805 on Day1
BW-20805-2Drug
Group 3 will receive SC administrations of BW-20805-2 on Day1.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BW-20805 (cohort 1, n=8) Receives: Drug: BW-20805 |
| Cohort 2 | Experimental | BW-20805 (cohort 2, n=8) Receives: Drug: BW-20805 |
| Cohort 3 | Experimental | BW-20805-2 (cohort 3, n=8) Receives: Drug: BW-20805-2 |
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) and serious adverse events (SAEs)
Measured: week 48
Secondary outcomes (1)
Secondary Endpoints
Maximum observed plasma concentration (Cmax), - Time to maximum plasma concentration (Tmax),
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start28 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion5 Nov 2027 (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
- None (open label)
- Enrolment
- 24 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
- NCT07528053
- Sponsor's protocol ID
- BW-20805-2-1001
- Acronym
- HV
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07528053
- Acronym / sponsor ID
- HV / BW-20805-2-1001
- Conditions
- HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 5 Nov 2027 (estimated)
- First posted
- 14 Apr 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 Clinical Study Of BW-20805-2-1001 in Healthy Participants
Detailed description
A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BW-20805BW-20805 (cohort 1, n=8) |
| Cohort 2 | Experimental | Drug: BW-20805BW-20805 (cohort 2, n=8) |
| Cohort 3 | Experimental | Drug: BW-20805-2BW-20805-2 (cohort 3, n=8) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must have given written informed consent and be able to comply with all study requirements
- Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
- Body mass index (BMI) ≥18 and ≤32 kg/m2 and body weight ≥50 kg 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 48 weeks following administration of the study drug
Key exclusion criteria (22 listed)
- Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that
- Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site
- Hospitalization for any reason within 60 days prior to screening.
- Presence of carcinoma and history of carcinoma
- 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-20805Cohort 1 will receive SC administrations of BW-20805 on Day1. | Drug | Cohort 1 |
| BW-20805Group 2 will receive SC administrations of BW-20805 on Day1 | Drug | Cohort 2 |
| BW-20805-2Group 3 will receive SC administrations of BW-20805-2 on Day1. | Drug | Cohort 3 |
Primary outcome
Primary Endpoints
Time frame: week 48
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
1 secondary outcome
Secondary Endpoints
Time frame: week 48
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 21 Apr 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 testing BW-20805 and BW-20805-2 in people with 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 4 inclusion and 22 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: opening soon, as of the sponsor's last update on 21 Apr 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 Manxue Jia (+1-929-231-3324, manxue.jia@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: week 48). 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 21 Apr 2026.