Healthy Participants Study
Conditions
Brief summary
Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants
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
Interventions
Solution for injection
DRUGSaline (0.9% NaCl)
Solution for injection
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | From pre-dose up to Day 8 | Evaluation of the maximum plasma concentration of BW-50218. |
| Time to Maximum Plasma Concentration (Tmax) | From pre-dose up to Day 8 | Evaluation of the time to reach maximum plasma concentration. |
| Area Under the Plasma Concentration-Time Curve (AUC) | 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). |
| Terminal Elimination Half-Life (t1/2) | From pre-dose up to Day 8 | Evaluation of the elimination half-life of BW-50218. |
| Urine Pharmacokinetic Parameters | From pre-dose up to 24 hours post-dose | Evaluation of urine output (Aet) and renal clearance (CLr). |
| Change from Baseline in Serum Transthyretin (TTR) Protein Concentration | From baseline up to Day 360 (End of Study) | Assessment of the concentration of Transthyretin (TTR) protein in serum to evaluate pharmacodynamic response. |
Countries
Australia
Contacts
STUDY_DIRECTORYuqiong Li, MD
Shanghai Argo Biopharmaceutical Co., Ltd.
Outcome results
None listed