Healthy Volunteer
Conditions
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?
Interventions
DRUGALN-F1202
Administered per the protocol
DRUGMatching Placebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Up to 190 Days |
| Severity of TEAEs | Up to 190 Days |
Secondary
| 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 |
Countries
Belgium
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed