Study of BW-50218 in Healthy Participants
ConditionHealthy Participants Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Argo Biopharmaceutical Co., Ltd.
About this trial
Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BW-50218 Injection
DrugSolution for injection
Saline (0.9% NaCl)
DrugSolution for injection
Treatment groups
60 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: BW-50218 Dose 1Experimental treatment 1 intervention
Group B: BW-50218 Dose 2Experimental treatment 1 intervention
Group C: BW-50218 Dose 3Experimental treatment 1 intervention
Group D: BW-50218 Dose 4Experimental treatment 1 intervention
Group E: BW-50218 Dose 5Experimental treatment 1 intervention
Group F: BW-50218 Dose 6Experimental treatment 1 intervention
Group G: Saline PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From baseline up to Day 360 (End of Study)2
Change from Baseline in Clinical Laboratory Test Results
Evaluation of hematology, clinical chemistry, and urinalysis parameters.
Time frame
From baseline up to Day 360 (End of Study)3
Change from Baseline in Vital Signs
Evaluation of blood pressure, heart rate, respiratory rate, and body temperature.
Time frame
From baseline up to Day 360 (End of Study)4
Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters
Evaluation of PR, QRS, QT, and QTc intervals.
Time frame
From baseline up to Day 360 (End of Study)Secondary outcomes
1
Maximum Observed Plasma Concentration (Cmax)
Evaluation of the maximum plasma concentration of BW-50218.
Time frame
From pre-dose up to Day 82
Time to Maximum Plasma Concentration (Tmax)
Evaluation of the time to reach maximum plasma concentration.
Time frame
From pre-dose up to Day 83
Area Under the Plasma Concentration-Time Curve (AUC)
Evaluation of AUC from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf).
Time frame
From pre-dose up to Day 84
Terminal Elimination Half-Life (t1/2)
Evaluation of the elimination half-life of BW-50218.
Time frame
From pre-dose up to Day 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov