Study of BW-50218 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-50218 in Healthy Participants

Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants Study
• Intervention / Treatment: Drug: BW-50218 Injection; Drug: Saline (0.9% NaCl)

Detailed Description

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhi Hua; Phone Number: +86 185 1618 7545; Email: zhi.hua@argobiopharma.com

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • CMAX Clinical Research Pty Ltd
      • Contact: Sarada Radha; Phone Number: +61 8 7088 7900; Email: Sarada.Radha@cmax.com.au
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Not yet recruiting
      • Linear Early Fhase Limited
      • Contact: Jasmine Cahill Loring; Phone Number: +61 8 6382 5100; Email: jloring@linear.org.au

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Capable of providing written informed consent and complying with all study procedures for the duration of the study.
• Body weight and body mass index (BMI) within a range considered appropriate for study participation by the investigator.
• Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
• Male participants with partners of childbearing potential must agree to use effective contraception.

Exclusion Criteria:

• Any medical condition, recent illness, or laboratory result that, in the investigator's opinion, may increase risk or interfere with participation in the study.
• Recent hospitalization or a significant acute medical event.
• History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
• Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
• Positive test for hepatitis B, hepatitis C, or HIV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BW-50218 Dose 1; Single dose of BW-50218 injection (Dose 1).	Drug: BW-50218 Injection; Solution for injection
Experimental: BW-50218 Dose 2; Single dose of BW-50218 injection (Dose 2).	Drug: BW-50218 Injection; Solution for injection
Experimental: BW-50218 Dose 3; Single dose of BW-50218 injection (Dose 3).	Drug: BW-50218 Injection; Solution for injection
Experimental: BW-50218 Dose 4; Single dose of BW-50218 injection (Dose 4).	Drug: BW-50218 Injection; Solution for injection
Experimental: BW-50218 Dose 5; Single dose of BW-50218 injection (Dose 5).	Drug: BW-50218 Injection; Solution for injection
Experimental: BW-50218 Dose 6; Single dose of BW-50218 injection (Dose 6).	Drug: BW-50218 Injection; Solution for injection
Placebo Comparator: Saline Placebo; Single dose of Saline Placebo	Drug: Saline (0.9% NaCl); Solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events. The severity of AEs will be assessed and categorized according to the "Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).	From baseline up to Day 360 (End of Study)
Change from Baseline in Clinical Laboratory Test Results	Evaluation of hematology, clinical chemistry, and urinalysis parameters.	From baseline up to Day 360 (End of Study)
Change from Baseline in Vital Signs	Evaluation of blood pressure, heart rate, respiratory rate, and body temperature.	From baseline up to Day 360 (End of Study)
Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters	Evaluation of PR, QRS, QT, and QTc intervals.	From baseline up to Day 360 (End of Study)
Change from Baseline in Physical Examination Findings	Assessment of clinically significant changes in physical examination findings.	From baseline up to Day 360 (End of Study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Evaluation of the maximum plasma concentration of BW-50218.	From pre-dose up to Day 8
Time to Maximum Plasma Concentration (Tmax)	Evaluation of the time to reach maximum plasma concentration.	From pre-dose up to Day 8
Area Under the Plasma Concentration-Time Curve (AUC)	Evaluation of AUC from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf).	From pre-dose up to Day 8
Terminal Elimination Half-Life (t1/2)	Evaluation of the elimination half-life of BW-50218.	From pre-dose up to Day 8
Urine Pharmacokinetic Parameters	Evaluation of urine output (Aet) and renal clearance (CLr).	From pre-dose up to 24 hours post-dose
Change from Baseline in Serum Transthyretin (TTR) Protein Concentration	Assessment of the concentration of Transthyretin (TTR) protein in serum to evaluate pharmacodynamic response.	From baseline up to Day 360 (End of Study)

Collaborators and Investigators

• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
• Investigators: Study Director: Yuqiong Li, MD, Shanghai Argo Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: BW-50218-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.

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.: No