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Completed

NCT Number: NCT06675565

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Montreal, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALN-AGT01 RVR

Drug

ALN-AGT01 RVR will be administered subcutaneously (SC)

Placebo

Drug

Placebo will be administered SC

Primary outcomes

  1. Frequency of Adverse Events (AEs)

    Time frame: Up to 3 months

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma

    Time frame: Predose and up to 3 days postdose

  2. Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma

    Time frame: Predose and up to 3 days postdose

  3. Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma

    Time frame: Predose and up to 3 days postdose

  4. Concentrations of ALN-AGT01 RVR in Urine

    Time frame: Predose and up to 1 day postdone

    Fraction of ALN-AGT01 RVR excreted in urine

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ALN-AGT01 RVR in Adult Healthy Volunteers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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