Healthy VolunteerPhase 1NCT06669234
Phase 1 Safety and Tolerability Study of ALN-F1202 in Healthy Adults
A Phase 1 study testing ALN-F1202 in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ALN-F1202
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Mar 2025to 4 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)
Leuven, Vlaams-Brabant, 3000
About this study
Official 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
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
- Being tested
- ALN-F1202, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-F1202Drug
Administered per the protocol
Matching PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| ALN-F1202 | Experimental | Randomized as described in the protocol Escalating Cohorts including Optional Cohorts Receives: Drug: ALN-F1202 |
| Placebo | Experimental | Randomized as described in the protocol Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 190 Days
Severity of TEAEs
Measured: Up to 190 Days
Secondary outcomes (4)
Change in activated Partial Thromboplastin Time (aPTT)
Measured: Baseline up to 190 Days
Change in Prothrombin Time (PT)
Measured: Baseline up to 190 Days
Concentration of combined ALN-F1202 and metabolites in plasma
Measured: Up to 190 Days
Extent of urinary excretion of combined ALN-F1202 and metabolites
Measured: Within 24 hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start6 Mar 2025
- Primary completion30 Jul 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669234
- Sponsor's protocol ID
- ALN-F1202-HV-2412
- Other IDs
- 2024-515286-34-00
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06669234
- Acronym / sponsor ID
- ALN-F1202-HV-2412
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALN-F1202 | Experimental | Drug: ALN-F1202Randomized as described in the protocol Escalating Cohorts including Optional Cohorts |
| Placebo | Experimental | Drug: Matching PlaceboRandomized as described in the protocol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-F1202Administered per the protocol | Drug | ALN-F1202 |
| Matching PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 190 Days
Severity of TEAEs
Time frame: Up to 190 Days
4 secondary outcomes
Change in activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline up to 190 Days
Change in Prothrombin Time (PT)
Time frame: Baseline up to 190 Days
Concentration of combined ALN-F1202 and metabolites in plasma
Time frame: Up to 190 Days
Extent of urinary excretion of combined ALN-F1202 and metabolites
Time frame: Within 24 hours of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALN-F1202 in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 190 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.