NCT05661916

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALN-TTRSC04 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneously Administered ALN-TTRSC04 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending doses of ALN-TTRSC04.

Conditions

• Transthyretin-Mediated Amyloidosis

Interventions

Type	Name	Description
DRUG	ALN-TTRSC04	ALN-TTRSC04 will be administered by subcutaneous (SC) injection.
DRUG	Placebo	Placebo will be administered by SC injection.

Timeline

• Start date: 2023-01-16
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2022-12-22
• Last updated: 2026-02-17

Locations

1 site across 1 country: United Kingdom