Phase 1 Safety and Tolerability Study of ALN-F1202 in Healthy Adults

Phase 1

Recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: ALN-F1202; Drug: Matching Placebo

• Registration Number: NCT06669234
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This clinical research trial will evaluate the safety and tolerability of an experimental drug, ALN-F1202, in healthy participants.

The purpose of this trial is to learn about how safe and tolerable the experimental drug is. The trial is looking at several other research questions, including:

* What side effects may happen from taking the experimental drug?

* How much experimental drug is in the blood at different times?

* Whether the body makes antibodies against the experimental drug (which could make the drug less effective or could lead to side effects).

* What is the best dose of the experimental drug?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-11-01
• Status Verified: 2025-03
• Study Start: 2025-03-06
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALN-F1202	ALN-F1202	Randomized as described in the protocol Escalating Cohorts including Optional Cohorts
Placebo	Matching Placebo	Randomized as described in the protocol

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (TEAEs)	Up to 190 Days
Severity of TEAEs	Up to 190 Days

Secondary Outcome Measures

Name	Time	Method
Change in activated Partial Thromboplastin Time (aPTT)	Baseline up to 190 Days
Change in Prothrombin Time (PT)	Baseline up to 190 Days
Concentration of combined ALN-F1202 and metabolites in plasma	Up to 190 Days
Extent of urinary excretion of combined ALN-F1202 and metabolites	Within 24 hours of treatment

Trial Locations

Locations (1)

Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven); 🇧🇪 Leuven, Belgium