Not Yet RecruitingPhase 1

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

China24 participantsStarted 2026-05-15

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)

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

Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.

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

Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.

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

Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.

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

Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.

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

Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.

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

Trial details

NCT IDNCT07577479

SponsorShanghai Argo Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Zhi Hua

+86 185 1618 7545 zhi.hua@argobiopharma.com

View on ClinicalTrials.gov More Healthy Participants Study trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)

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

Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.

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

Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.

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

Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.

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

Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.

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

Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.

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