A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants

NCT07528053 | Not Yet Recruiting Phase 1

• 1 other identifier: BW-20805-2-1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants

Conditions

HV

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints

  Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  week 48

Secondary Outcomes (1)

• Secondary Endpoints

  week 48

Study Arms (3)

Cohort 1

EXPERIMENTAL

BW-20805 (cohort 1, n=8)

Drug: BW-20805

Cohort 2

EXPERIMENTAL

BW-20805 (cohort 2, n=8)

Drug: BW-20805

Cohort 3

EXPERIMENTAL

BW-20805-2 (cohort 3, n=8)

Drug: BW-20805-2

Interventions

BW-20805 DRUG

Cohort 1 will receive SC administrations of BW-20805 on Day1.

Cohort 1

BW-20805-2 DRUG

Group 3 will receive SC administrations of BW-20805-2 on Day1.

Cohort 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Shanghai Argo Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Argo Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Central Study Contacts

Manxue Jia

CONTACT

+1-929-231-3324; manxue.jia@argobiopharma.com

Yan NA Yang

CONTACT

+86 18616176786; yan.yang@argobiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 5, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)