ALN-4285 single ascending doses in healthy adults
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-4285 in Adult Healthy Volunteers
This test will give single ascending doses of ALN-4285 or placebo to healthy adult volunteers to see if the drug is safe and how it behaves in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07295717 on ClinicalTrials.gov |
What this trial studies
This Phase 1, randomized, placebo-controlled study enrolls healthy adult volunteers to receive single ascending doses of ALN-4285 or placebo. The trial's primary objectives are to characterize safety, tolerability, and single-dose pharmacokinetics. Participants must meet criteria for BMI, ECG, liver and kidney function, and blood pressure and must not have recent exposure to other investigational agents. The study is sponsored by Alnylam Pharmaceuticals and conducted at a clinical site in London.
Who should consider this trial
Good fit: Healthy adults with BMI 18.0–30 kg/m^2, normal or nonclinically significant ECG, normal liver tests and eGFR ≥90 mL/min/1.73 m^2, controlled blood pressure, and no recent investigational drug exposure are the intended participants.
Not a fit: People with elevated liver enzymes or bilirubin, reduced kidney function, uncontrolled hypertension, or recent participation in other investigational drug studies are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, the results could enable further development of ALN-4285 and support a new RNAi-based treatment option for future patients.
How similar studies have performed: Other RNAi therapeutics from Alnylam and competitors have reached approval and early-phase studies of similar agents have shown predictable PK and manageable safety, but ALN-4285 itself is a novel candidate in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has a body mass index (BMI) of ≥18.0 kg/m\^2 and ≤30 kg/m\^2 * Has 12-lead ECG within normal limits or with no clinically significant abnormalities in the opinion of the Investigator Exclusion Criteria: * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN) * Has total bilirubin \>ULN * Has systolic blood pressure \>140 mmHg and/or a diastolic blood pressure \>90 mmHg * Has an estimated glomerular filtration (eGFR) of \<90 mL/min/1.73m\^2 at screening * Has received an investigational agent within the last 30 days or 5 half-lives
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.