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Active, Not Recruiting

NCT Number: NCT06669234

Phase 1 Safety and Tolerability Study of ALN-F1202 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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

ALN-F1202

Drug

Administered per the protocol

Matching Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 190 Days

  2. Severity of TEAEs

    Time frame: Up to 190 Days

Secondary outcomes

  1. Change in activated Partial Thromboplastin Time (aPTT)

    Time frame: Baseline up to 190 Days

  2. Change in Prothrombin Time (PT)

    Time frame: Baseline up to 190 Days

  3. Concentration of combined ALN-F1202 and metabolites in plasma

    Time frame: Up to 190 Days

  4. Extent of urinary excretion of combined ALN-F1202 and metabolites

    Time frame: Within 24 hours of treatment

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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