Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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).
Change from Baseline in Clinical Laboratory Test Results — From baseline up to Day 360 (End of Study) Evaluation of hematology, clinical chemistry, and urinalysis parameters.
Change from Baseline in Vital Signs — From baseline up to Day 360 (End of Study) Evaluation of blood pressure, heart rate, respiratory rate, and body temperature.
Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters — From baseline up to Day 360 (End of Study) Evaluation of PR, QRS, QT, and QTc intervals.
Change from Baseline in Physical Examination Findings — From baseline up to Day 360 (End of Study) Assessment of clinically significant changes in physical examination findings.
Trial sites (2)
Facility
City
Region
Status
CMAX Clinical Research Pty Ltd
Adelaide
South Australia
Linear Early Fhase Limited
Nedlands
Western Australia
More Shanghai Argo Biopharmaceutical Co., Ltd. trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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