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

NCT ID: NCT06675565

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-09-08

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ALN-AGT01 RVR

Participants will be administered a single dose of ALN-AGT01 RVR.

Group Type EXPERIMENTAL

ALN-AGT01 RVR

Intervention Type DRUG

ALN-AGT01 RVR will be administered subcutaneously (SC)

Placebo

Participants will be administered a single dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered SC

Interventions

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ALN-AGT01 RVR

ALN-AGT01 RVR will be administered subcutaneously (SC)

Intervention Type DRUG

Placebo

Placebo will be administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trial Site

Montreal, , Canada

Site Status

Countries

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Canada

Other Identifiers

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ALN-AGT01 RVR-001

Identifier Type: -

Identifier Source: org_study_id

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