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

NCT06669234 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: ALN-F1202-HV-24122024-515286-34-00
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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?

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Up to 190 Days

• Severity of TEAEs

  Up to 190 Days

Secondary Outcomes (4)

• 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

Study Arms (2)

ALN-F1202

EXPERIMENTAL

Randomized as described in the protocol Escalating Cohorts including Optional Cohorts

Drug: ALN-F1202

Placebo

EXPERIMENTAL

Randomized as described in the protocol

Drug: Matching Placebo

Interventions

ALN-F1202 DRUG

Administered per the protocol

ALN-F1202

Matching Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has a body mass index between 18 and 32 kg/m2, inclusive
• 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
• Is in good health based on laboratory safety testing obtained at the screening visit, as described in the protocol
• Normal aPTT, normal PT, and normal platelet counts at screening period and at day -1 as defined by the local laboratory
• Hemoglobin values at screening period and at day -1 as described in the protocol

You may not qualify if:

• 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
• Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening
• 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
• History of bleeding diathesis as described in the protocol
• Members of the clinical site study team and/or his/her immediate family, unless prior approval granted by the sponsor
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

BE (1)