Safety and tolerability evaluation of ALN-F1202 in healthy adults

A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ALN-F1202, an siRNA Against Factor XII, in Healthy Adults

This study tests a new drug called ALN-F1202 in healthy adults to see if it's safe and how well the body tolerates it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (Industry-sponsored)
• Locations: 1 site (Leuven)
• Trial ID: NCT06669234 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of an experimental drug, ALN-F1202, in healthy adult participants. The study aims to identify potential side effects, measure drug levels in the blood over time, assess the body's immune response to the drug, and determine the optimal dosage. Participants will receive either the experimental drug or a matching placebo. The findings will help inform future studies and potential therapeutic applications of ALN-F1202.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a body mass index between 18 and 32 kg/m2.

Not a fit: Patients with a history of major surgical procedures or significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety profile of ALN-F1202, paving the way for its use in treating various conditions.

How similar studies have performed: Other studies evaluating the safety of similar experimental drugs have shown success, indicating that this approach is well-established.

Eligibility criteria

Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m2, inclusive
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
3. Is in good health based on laboratory safety testing obtained at the screening visit, as described in the protocol
4. Normal aPTT, normal PT, and normal platelet counts at screening period and at day -1 as defined by the local laboratory
5. Hemoglobin values at screening period and at day -1 as described in the protocol

Key Exclusion Criteria:

1. History of any major surgical procedure or clinically significant physical trauma, in the opinion of the investigator, that may pose a risk to the participant by study participation
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening
3. History of clinically significant bleeding, requiring hospitalization or blood products, that in the opinion of the investigator may pose a risk to the participant by study participation
4. History of bleeding diathesis as described in the protocol
5. Members of the clinical site study team and/or his/her immediate family, unless prior approval granted by the sponsor
6. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Where this trial is running

Leuven

• Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) — Leuven, Belgium (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions Healthy Volunteer