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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 -
- •Positive test for hepatitis B, hepatitis C, or HIV.
Arms & Interventions
BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3).
Intervention: BW-50218 Injection (Drug)
BW-50218 Dose 5
Single dose of BW-50218 injection (Dose 5).
Intervention: BW-50218 Injection (Drug)
BW-50218 Dose 6
Single dose of BW-50218 injection (Dose 6).
Intervention: BW-50218 Injection (Drug)
BW-50218 Dose 1
Single dose of BW-50218 injection (Dose 1).
Intervention: BW-50218 Injection (Drug)
BW-50218 Dose 4
Single dose of BW-50218 injection (Dose 4).
Intervention: BW-50218 Injection (Drug)
Saline Placebo
Single dose of Saline Placebo
Intervention: Saline (0.9% NaCl) (Drug)
BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2).
Intervention: BW-50218 Injection (Drug)
Outcomes
Primary Outcomes
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).
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.
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.
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.
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.
Secondary Outcomes
- 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)
- Change from Baseline in Serum Transthyretin (TTR) Protein Concentration(From baseline up to Day 360 (End of Study))