ALN-6400 for Healthy Volunteers

Overseen By Alnylam Clinical Trial Information Line

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alnylam Pharmaceuticals

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers.

Research Team

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

I am a healthy adult.

Exclusion Criteria

Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)

I have HIV or chronic hepatitis B or C.

Is not willing to comply with the contraceptive requirements during the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ALN-6400 or placebo

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALN-6400

Trial Overview 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.

Participant Groups

Group I: ALN-6400 Experimental Treatment 1 Intervention

Participants will be administered a single dose of ALN-6400.

Group II: Placebo Placebo Group 1 Intervention

Participants will be administered a single dose of placebo.

Who Is Running the Clinical Trial?

Alnylam Pharmaceuticals

Lead Sponsor

Trials

81

Recruited

16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University