Study of BW-50218 in Healthy Participants

September 2, 2026 updated by: Shanghai Argo Biopharmaceutical Co., Ltd.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • CMAX Clinical Research Pty Ltd
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Early Fhase Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BW-50218 Dose 1
Single dose of BW-50218 injection (Dose 1).
Drug: BW-50218 Injection
Solution for injection
Experimental: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2).
Drug: BW-50218 Injection
Solution for injection
Experimental: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3).
Drug: BW-50218 Injection
Solution for injection
Experimental: BW-50218 Dose 4
Single dose of BW-50218 injection (Dose 4).
Drug: BW-50218 Injection
Solution for injection
Experimental: BW-50218 Dose 5
Single dose of BW-50218 injection (Dose 5).
Drug: BW-50218 Injection
Solution for injection
Experimental: BW-50218 Dose 6
Single dose of BW-50218 injection (Dose 6).
Drug: BW-50218 Injection
Solution for injection
Placebo Comparator: Saline Placebo
Single dose of Saline Placebo
Drug: Saline (0.9% NaCl)
Solution for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: From baseline up to Day 360 (End of Study)
Evaluation of hematology, clinical chemistry, and urinalysis parameters.
From baseline up to Day 360 (End of Study)
Change from Baseline in Vital Signs
Time Frame: From baseline up to Day 360 (End of Study)
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
Time Frame: From baseline up to Day 360 (End of Study)
Evaluation of PR, QRS, QT, and QTc intervals.
From baseline up to Day 360 (End of Study)
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.
From baseline up to Day 360 (End of Study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: From pre-dose up to Day 8
Evaluation of the maximum plasma concentration of BW-50218.
From pre-dose up to Day 8
Time to Maximum Plasma Concentration (Tmax)
Time Frame: From pre-dose up to Day 8
Evaluation of the time to reach maximum plasma concentration.
From pre-dose up to Day 8
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).
From pre-dose up to Day 8
Terminal Elimination Half-Life (t1/2)
Time Frame: From pre-dose up to Day 8
Evaluation of the elimination half-life of BW-50218.
From pre-dose up to Day 8
Urine Pharmacokinetic Parameters
Time Frame: From pre-dose up to 24 hours post-dose
Evaluation of urine output (Aet) and renal clearance (CLr).
From pre-dose up to 24 hours post-dose
Change from Baseline in Serum Transthyretin (TTR) Protein Concentration
Time Frame: From baseline up to Day 360 (End of Study)
Assessment of the concentration of Transthyretin (TTR) protein in serum to evaluate pharmacodynamic response.
From baseline up to Day 360 (End of Study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Argo Biopharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yuqiong Li, MD, Shanghai Argo Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BW-50218-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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