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RNA-based Therapy

ALN-6400 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 a healthy adult volunteer
Be older than 18 years old
Must not have
Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
Has an estimated glomerular filtration (eGFR) of <90 mL/min/1.73m^2 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to test the safety and effectiveness of different doses of ALN-6400 in healthy volunteers.

Who is the study for?
This trial is for healthy adult volunteers who want to help test a new medication. There are specific requirements and exclusions that aren't listed here, but generally, participants should be in good health without any significant medical conditions.
What is being tested?
The study is testing ALN-6400, which is a new drug. Participants will receive either the actual drug or a placebo (a substance with no therapeutic effect) to compare outcomes. The focus is on how safe it is and how the body responds to different doses.
What are the potential side effects?
Since this information isn't provided directly, side effects are typically determined during the trial. They can range from none at all to various reactions depending on individual tolerance and the nature of ALN-6400.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALN-6400Experimental Treatment1 Intervention
Participants will be administered a single dose of ALN-6400.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered a single dose of placebo.

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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
16,033 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,905 Previous Clinical Trials
8,091,457 Total Patients Enrolled
~21 spots leftby Sep 2025
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