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

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

Study Overview

• Status: Not yet recruiting
• Conditions: HV
• Intervention / Treatment: Drug: BW-20805; Drug: BW-20805; Drug: BW-20805-2

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Manxue Jia; Phone Number: +1-929-231-3324; Email: manxue.jia@argobiopharma.com
• Study Contact Backup: Name: Yan NA Yang; Phone Number: +86 18616176786; Email: yan.yang@argobiopharma.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Argo Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; BW-20805 (cohort 1, n=8)	Drug: BW-20805; Cohort 1 will receive SC administrations of BW-20805 on Day1.; Drug: BW-20805; Group 2 will receive SC administrations of BW-20805 on Day1
Experimental: Cohort 2; BW-20805 (cohort 2, n=8)	Drug: BW-20805; Cohort 1 will receive SC administrations of BW-20805 on Day1.; Drug: BW-20805; Group 2 will receive SC administrations of BW-20805 on Day1
Experimental: Cohort 3; BW-20805-2 (cohort 3, n=8)	Drug: BW-20805-2; Group 3 will receive SC administrations of BW-20805-2 on Day1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoints	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoints	Maximum observed plasma concentration (Cmax), - Time to maximum plasma concentration (Tmax),	week 48

Collaborators and Investigators

• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 5, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BW-20805-2-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes