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NCT Number: NCT07401472

Study of BW-50218 in Healthy Participants

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

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Key information

Conditions

Healthy Participants Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research Pty Ltd, Adelaide, South Australia, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BW-50218 Injection

Drug

Solution for injection

Saline (0.9% NaCl)

Drug

Solution for injection

Primary outcomes

  1. Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From baseline up to Day 360 (End of Study)

    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).

  2. Change from Baseline in Clinical Laboratory Test Results

    Time frame: From baseline up to Day 360 (End of Study)

    Evaluation of hematology, clinical chemistry, and urinalysis parameters.

  3. Change from Baseline in Vital Signs

    Time frame: From baseline up to Day 360 (End of Study)

    Evaluation of blood pressure, heart rate, respiratory rate, and body temperature.

  4. Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters

    Time frame: From baseline up to Day 360 (End of Study)

    Evaluation of PR, QRS, QT, and QTc intervals.

  5. Change from Baseline in Physical Examination Findings

    Time frame: From baseline up to Day 360 (End of Study)

    Assessment of clinically significant changes in physical examination findings.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: From pre-dose up to Day 8

    Evaluation of the maximum plasma concentration of BW-50218.

  2. Time to Maximum Plasma Concentration (Tmax)

    Time frame: From pre-dose up to Day 8

    Evaluation of the time to reach maximum plasma concentration.

  3. Area Under the Plasma Concentration-Time Curve (AUC)

    Time frame: From pre-dose up to Day 8

    Evaluation of AUC from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf).

  4. Terminal Elimination Half-Life (t1/2)

    Time frame: From pre-dose up to Day 8

    Evaluation of the elimination half-life of BW-50218.

  5. Urine Pharmacokinetic Parameters

    Time frame: From pre-dose up to 24 hours post-dose

    Evaluation of urine output (Aet) and renal clearance (CLr).

  6. Change from Baseline in Serum Transthyretin (TTR) Protein Concentration

    Time frame: From baseline up to Day 360 (End of Study)

    Assessment of the concentration of Transthyretin (TTR) protein in serum to evaluate pharmacodynamic response.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi Hua

CONTACT

[email protected]

+86 185 1618 7545

Sponsors and collaborators

Lead sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study 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-50218 in Healthy Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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