Study of BW-50218 in Healthy Participants

NCT07401472 | Recruiting Phase 1

• 1 other identifier: BW-50218-1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Participants Study

Outcome Measures

Primary Outcomes (5)

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

  From baseline up to Day 360 (End of Study)

• Change from Baseline in Clinical Laboratory Test Results

  Evaluation of hematology, clinical chemistry, and urinalysis parameters.

  From baseline up to Day 360 (End of Study)

• Change from Baseline in Vital Signs

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

  From baseline up to Day 360 (End of Study)

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

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

  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)

Secondary Outcomes (6)

• 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

  From pre-dose up to 24 hours post-dose

Study Arms (7)

BW-50218 Dose 1

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

BW-50218 Dose 4

EXPERIMENTAL

Single dose of BW-50218 injection (Dose 4).

Drug: BW-50218 Injection

BW-50218 Dose 5

EXPERIMENTAL

Single dose of BW-50218 injection (Dose 5).

Drug: BW-50218 Injection

BW-50218 Dose 6

EXPERIMENTAL

Single dose of BW-50218 injection (Dose 6).

Drug: BW-50218 Injection

Saline Placebo

PLACEBO COMPARATOR

Single dose of Saline Placebo

Drug: Saline (0.9% NaCl)

Interventions

BW-50218 Injection DRUG

Solution for injection

BW-50218 Dose 1; BW-50218 Dose 2; BW-50218 Dose 3; BW-50218 Dose 4; BW-50218 Dose 5; BW-50218 Dose 6

Saline (0.9% NaCl) DRUG

Solution for injection

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Argo Biopharmaceutical Co., Ltd.: lead

Study Sites (2)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

RECRUITING

Linear Early Fhase Limited

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yuqiong Li, MD

  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: January 26, 2026
• First Posted: February 10, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

AU (2)