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

Last updated: January 8, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1

Condition

Amyloidosis

Treatment

ALN-TTRSC04

Placebo

Clinical Study ID

NCT05661916
ALN-TTRSC04-001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) ≥18.0 kg/m^2 and ≤30 kg/m^2 assessed at Screening.

Exclusion

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 directbilirubin above the upper limit of normal (ULN).

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: ALN-TTRSC04
Phase: 1
Study Start date:
January 16, 2023
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • Clinical Trial Site

    London,
    United Kingdom

    Active - Recruiting

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