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RecruitingPhase 1NCT07577479

A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants

Sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Enrollment

24 participants

Start Date

May 18, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants Study

Summary

A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • Capable of providing written informed consent and complying with all study procedures for the duration of the study.
  • Body weight > 50 kg for males and > 45 kg for females; 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 Criteria5

  • Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for 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.

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Interventions

DRUGBW-50218 Injection

Solution for injection

DRUGSaline (0.9% NaCl)

Solution for injection

Locations(1)

Argo Investigative Site

Shanghai, China

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NCT07577479

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