Phase 1 Safety and Tolerability Study 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 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?

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ALN-F1202; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Randomized as described in the protocol	Drug: Matching Placebo; Administered per the protocol
Experimental: ALN-F1202; Randomized as described in the protocol Escalating Cohorts including Optional Cohorts	Drug: ALN-F1202; Administered per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs)	Up to 190 Days
Severity of TEAEs	Up to 190 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ALN-F1202-HV-2412; 2024-515286-34-00 (Ctis: EUCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes