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NCT Number: NCT07577479

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Participants Study

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Argo Investigative Site

Shanghai, China

About this study

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

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 Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).

  2. 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.

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

  3. 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.

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

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

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

  5. 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.

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

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

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

  7. Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be fagged.

  8. Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group

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

    Abnormal physical examination findings will be listed.

  9. Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.

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

    Abnormal physical examination findings will be listed.

  10. Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.

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

    Abnormal physical examination findings will be listed.

  11. Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.

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

    Abnormal physical examination findings will be listed.

  12. Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.

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

    12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).

  13. Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.

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

    12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).

  14. 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

  15. Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.

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

    The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.

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 (Renal Clearance, CLr)

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

    Renal clearance calculated as CLr = CAe/Plasma AUC 0-24. Ae=cumulative amount excreted in urine (mg). AUC 0-24 = Area under the plasma concentration - time curve from 0 to 24 hours(e.g.mg*h/mL)

Sponsors and collaborators

Lead sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 11, 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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