Study of BW-50218 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BW-50218 Injection, Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Healthy Participants Study. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug BW-50218 Injection
Solution for injection - Drug Saline (0.9% NaCl)
Solution for injection
Primary outcome measures
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: 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)]
- Change from Baseline in Vital Signs [Time frame: 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)]
- Change from Baseline in Physical Examination Findings [Time frame: From baseline up to Day 360 (End of Study)]
Secondary outcome measures (6)
- Maximum Observed Plasma Concentration (Cmax) [Time frame: From pre-dose up to Day 8]
- Time to Maximum Plasma Concentration (Tmax) [Time frame: From pre-dose up to Day 8]
- Area Under the Plasma Concentration-Time Curve (AUC) [Time frame: From pre-dose up to Day 8]
- Terminal Elimination Half-Life (t1/2) [Time frame: From pre-dose up to Day 8]
- Urine Pharmacokinetic Parameters [Time frame: 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 2 centers
- CMAX Clinical Research Pty Ltd — Adelaide
- Linear Early Fhase Limited — Nedlands
Identifiers
NCT: NCT07401472 · BW-50218-1001