A Study to Evaluate ALN-AGT01 RVR in Adult Healthy Volunteers

Last updated: September 17, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

ALN-AGT01 RVR

Placebo

Clinical Study ID

NCT06675565
ALN-AGT01 RVR-001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Is an adult healthy volunteer

  • Has a body mass index ≥18 kg/m^2 and ≤28 kg/m^2

Exclusion Criteria

  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)

  • Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

  • Has an estimated glomerular filtration rate (eGFR) of <90 mL/min/1.73m^2 at screening

Note: other protocol defined inclusion / exclusion criteria apply

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: ALN-AGT01 RVR
Phase: 1
Study Start date:
November 05, 2024
Estimated Completion Date:
September 08, 2025

Connect with a study center

  • Clinical Trial Site

    Montreal,
    Canada

    Site Not Available

  • Clinical Trial Site

    Montreal 6077243,
    Canada

    Site Not Available

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