A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALN-TTRSC04 in Healthy Subjects
Phase 1
Recruiting
- Conditions
- Transthyretin-Mediated Amyloidosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05661916
- Lead Sponsor
- Alnylam Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending doses of ALN-TTRSC04.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- Body mass index (BMI) ≥18.0 kg/m^2 and ≤30 kg/m^2 assessed at Screening.
Exclusion Criteria
- Has an estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m^2 at screening.
- Has alanine aminotransferase (ALT), aspartate aminotransferase (AST) or direct bilirubin above the upper limit of normal (ULN).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will be administered a single dose of placebo. ALN-TTRSC04 ALN-TTRSC04 Participants will be administered a single dose of ALN-TTRSC04.
- Primary Outcome Measures
Name Time Method Frequency of Adverse Events Up to 20 months
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve (AUC) of ALN-TTRSC04 Day 1 up to Day 4 Fraction of ALN-TTRSC04 Excreted in the Urine (fe) Up to Day 2 Time to Maximum Observed Plasma Concentration (Tmax) of ALN-TTRSC04 Day 1 up to Day 4 Maximum Observed Plasma Concentration (Cmax) of ALN-TTRSC04 Day 1 up to Day 4 Change from Baseline in Serum Transthyretin (TTR) Levels Over Time Up to 18 months
Trial Locations
- Locations (1)
Clinical Trial Site
🇬🇧London, United Kingdom