ALN-4915 in healthy adults
A Phase 1, Randomized, Double-Masked, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-4915 in Adult Healthy Volunteers
This will test ALN-4915 versus placebo in healthy adult volunteers to see if it is safe and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07535606 on ClinicalTrials.gov |
What this trial studies
This phase 1 interventional study enrolls healthy adult volunteers who will receive ALN-4915 or placebo and undergo clinical and laboratory monitoring. Participants will have serial blood sampling to measure pharmacokinetics (how the drug is absorbed and cleared) and pharmacodynamics (biological responses), along with safety and tolerability assessments. People with elevated liver enzymes, high bilirubin, or known complement or immune deficiencies are excluded to reduce risk and clarify PK/PD signals. The trial is sponsored by Alnylam Pharmaceuticals and conducted at a clinical site in London.
Who should consider this trial
Good fit: Ideal candidates are healthy adults who can complete all study visits and who have normal liver tests, normal bilirubin, and no history of immune or complement deficiencies.
Not a fit: People with elevated ALT/AST, high total bilirubin, known immune or complement deficiencies, or those seeking direct therapeutic benefit should not expect to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help guide development of safer and more effective siRNA therapies for future patients.
How similar studies have performed: Other siRNA programs, including prior Alnylam RNAi drugs, have achieved clinical success, but each new compound requires its own safety and PK testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Is willing and able to complete all study assessments Exclusion Criteria: * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN) * Has total bilirubin \>ULN * Has no history of invasive infection by an encapsulated organism * Has no known complement or immunologic deficiency
Where this trial is running
London
- Clinical Trial Site — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: 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.