Evaluating ALN-AGT01 RVR in Healthy Adults
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
This study is testing a new drug called ALN-AGT01 RVR in healthy adults to see if it's safe and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Montreal) |
| Trial ID | NCT06675565 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and pharmacokinetics of single ascending doses of ALN-AGT01 RVR in adult healthy volunteers. Participants will receive either the investigational drug or a placebo in a controlled setting. The study will follow a phased approach to gradually increase the dosage while monitoring for any adverse effects. The findings will help determine the appropriate dosing and safety profile of this RNAi therapeutic.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 and older with a body mass index between 18 and 28 kg/m².
Not a fit: Patients with liver dysfunction, chronic viral infections, or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new RNAi therapies that improve treatment options for various conditions.
How similar studies have performed: While RNAi therapeutics are a novel approach, similar studies have shown promise in evaluating safety and efficacy in healthy volunteers.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal
- Clinical Trial Site — Montreal, Canada (Recruiting)
Study contacts
- Study coordinator: Alnylam Clinical Trial Information Line
- Email: clinicaltrials@alnylam.com
- Phone: 1-877-ALNYLAM
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.