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RNA-targeted therapy

ALN-AGT01 RVR for Healthy Volunteers

Phase 1
Recruiting
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is an adult healthy volunteer
Be older than 18 years old
Must not have
Has an estimated glomerular filtration rate (eGFR) of <90 mL/min/1.73m^2 at screening
Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and up to 1 day postdone

Summary

This trial aims to test how safe and well-tolerated different doses of ALN-AGT01 RVR are, as well as how the body processes the drug.

Who is the study for?
This trial is for healthy adult volunteers who want to participate in a study evaluating the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.
What is being tested?
The trial is testing ALN-AGT01 RVR, which is likely a new drug. Participants will receive either this drug or a placebo (a substance with no therapeutic effect) to assess the drug's safety, how well it's tolerated by the body, and its pharmacokinetics (how it's processed by the body).
What are the potential side effects?
Since ALN-AGT01 RVR is under evaluation, specific side effects are unknown at this stage. However, common side effects in trials like these may include nausea, headaches, allergic reactions or other symptoms depending on how the body reacts to the new substance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy adult.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function test shows less than normal results.
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I have HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and up to 1 day postdone
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and up to 1 day postdone for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Concentrations of ALN-AGT01 RVR in Urine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALN-AGT01 RVRExperimental Treatment1 Intervention
Participants will be administered a single dose of ALN-AGT01 RVR.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered a single dose of placebo.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
79 Previous Clinical Trials
15,987 Total Patients Enrolled
~52 spots leftby Sep 2025