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

NCT07577479 | Not Yet Recruiting Phase 1

• 1 other identifier: BW-50218-1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants Study

Outcome Measures

Primary Outcomes (15)

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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From baseline up to Day 360 (End of Study)

• 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.

  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.

  From baseline up to Day 360 (End of Study)

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

  Abnormal physical examination findings will be listed.

  From baseline up to Day 360 (End of Study)

• 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.

  Abnormal physical examination findings will be listed.

  From baseline up to Day 360 (End of Study)

• 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.

  Abnormal physical examination findings will be listed.

  From baseline up to Day 360 (End of Study)

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

  Abnormal physical examination findings will be listed.

  From baseline up to Day 360 (End of Study)

• 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.

  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).

  From baseline up to Day 360 (End of Study)

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

  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).

  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)

• 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.

  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.

  From baseline up to Day 360 (End of Study)

Secondary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax)

  From pre-dose up to Day 8

• Time to Maximum Plasma Concentration (Tmax)

  From pre-dose up to Day 8

• Area Under the Plasma Concentration-Time Curve (AUC)

  From pre-dose up to Day 8

• Terminal Elimination Half-Life (t1/2)

  From pre-dose up to Day 8

• Urine Pharmacokinetic Parameters (Renal Clearance, CLr)

  From pre-dose up to 24 hours post-dose

Study Arms (4)

BW-50218 Dose1

EXPERIMENTAL

Single dose of BW-50218 injection (Dose 1)

Drug: BW-50218 Injection

BW-50218 Dose 2

EXPERIMENTAL

Single dose of BW-50218 injection (Dose 2)

Drug: BW-50218 Injection

BW-50218 Dose 3

EXPERIMENTAL

Single dose of BW-50218 injection (Dose 3)

Drug: BW-50218 Injection

Saline Placebo

PLACEBO COMPARATOR

Single dose of Saline Placebo

Drug: Saline (0.9% NaCl)

Interventions

Saline (0.9% NaCl) DRUG

Solution for injection

Saline Placebo

BW-50218 Injection DRUG

Solution for injection

BW-50218 Dose 2; BW-50218 Dose 3; BW-50218 Dose1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Argo Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Argo Investigative Site

Shanghai, China

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yuqiong Li

  Shanghai Argo Biopharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Zhi Hua

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 11, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)