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

September 17, 2025 updated by: Alnylam Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will be administered a single dose of placebo.
Drug: Placebo
Placebo will be administered SC
Experimental: ALN-AGT01 RVR
Participants will be administered a single dose of ALN-AGT01 RVR.
Drug: ALN-AGT01 RVR
ALN-AGT01 RVR will be administered subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events (AEs)
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma
Time Frame: Predose and up to 3 days postdose
Predose and up to 3 days postdose
Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma
Time Frame: Predose and up to 3 days postdose
Predose and up to 3 days postdose
Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma
Time Frame: Predose and up to 3 days postdose
Predose and up to 3 days postdose
Concentrations of ALN-AGT01 RVR in Urine
Time Frame: Predose and up to 1 day postdone
Fraction of ALN-AGT01 RVR excreted in urine
Predose and up to 1 day postdone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Actual)

September 8, 2025

Study Completion (Actual)

September 8, 2025

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-AGT01 RVR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on ALN-AGT01 RVR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe