Healthy VolunteerPhase 1NCT05603195
A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
A Phase 1 study testing REGN7508 (IV) and REGN7508 (SC) in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants. 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?
- REGN7508 (IV) and REGN7508 (SC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2023to 17 Sep 2024
- 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
- Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
- Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and echocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
- Participant is in good health based on laboratory safety testing obtained at the screening visit and/or prior to administration of initial dose of study drug
- Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT), and normal platelet counts at screening period and at the day -1 visit as defined by the local laboratory
- Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screening and day 1 visits
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 the screening visit
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation, as defined in the protocol
- Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening
- Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
- Confirmed positive drug test result at the screening visit and/or prior to randomization or a history of drug abuse within a year prior to the screening visit
Show all 10Show fewer
- History of alcohol abuse within the last 2 years prior to the day 1 visit
- Any malignancy, except for nonmelanoma skin cancer or cervical/anus in situ, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
- History of significant multiple and/or severe allergies (eg, latex gloves) or has had an anaphylactic reaction to prescription or nonprescription drugs or food
- NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7508, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects
This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.
This study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Conditions
- Healthy Volunteer
- Being tested
- REGN7508 (IV), REGN7508 (SC), Matching Placebo (IV), Matching Placebo (SC)
- Keywords
- Thrombotic disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7508 (IV)Drug
Administered sequential, ascending single intravenous (IV) dose
REGN7508 (SC)Drug
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (IV)Drug
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (SC)Drug
Administered sequential, ascending single subcutaneous (SC) dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Lowest IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (IV); Drug: Matching Placebo (IV) |
| Cohort 2 Low IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (IV); Drug: Matching Placebo (IV) |
| Cohort 3 Mid IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (IV); Drug: Matching Placebo (IV) |
| Cohort 4 High IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (IV); Drug: Matching Placebo (IV) |
| Cohort 5 Higher IV Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (IV); Drug: Matching Placebo (IV) |
| Cohort 6 High SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (SC); Drug: Matching Placebo (SC) |
| Cohort 7 Higher SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (SC); Drug: Matching Placebo (SC) |
| Optional: Cohort 8 Highest IV or SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (IV); Drug: REGN7508 (SC); Drug: Matching Placebo (IV); Drug: Matching Placebo (SC) |
| Cohort 9 High SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (SC); Drug: Matching Placebo (SC) |
| Optional: Cohort 10 Highest SC Dose | Experimental | Randomized 3:1 Receives: Drug: REGN7508 (SC); Drug: Matching Placebo (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of treatment-emergent adverse events (TEAE)
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Measured: Up to 36 days
Severity of TEAE
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Measured: Up to 36 days
Secondary outcomes (7)
Change from baseline in activated partial thromboplastin time (aPTT)
Measured: Up to 36 days
Change from baseline in prothrombin time (PT)
Measured: Up to 36 days
Concentrations of total REGN7508 in serum
Measured: Up to 36 days
Concentrations of functional REGN7508 in plasma
Measured: Up to 36 days
Absolute concentration and change from baseline in total Factor XI (FXI) concentrations
Measured: Up to 36 days
Absolute concentration and change from baseline in free FXI concentrations
Measured: Up to 36 days
Incidence of antidrug antibodies (ADAs) to REGN7508 over time
Measured: Up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start12 Jan 2023
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT05603195
- Sponsor's protocol ID
- R7508-HV-21102
- Other IDs
- 2022-002001-20
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2022
- Last updated
- 1 Oct 2024
- 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
Publications
Chalothorn D, Kithcart AP, Marin E, Somersan-Karakaya S, Lai K, Cauwberghs F, Ackroyd JPR, Mohammadi K, Shrestha A, Ehrlich GK, Rafique A, Chatterjee I, Saotome K, Franklin MC, Murphy AJ, Olson WC, Olenchock BA, Herman GA, Gutstein DE, Sirulnik A, Yancopoulos GD, Morton LG. Anticoagulation with mechanistically distinct FXI/FXIa antibodies amrecibart (REGN9933A2) and cenvacibart (REGN7508Cat). Blood. 2026 Jun 11:blood.2025032276. doi: 10.1182/blood.2025032276. Online ahead of print.
PubMed 42275249
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7508, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05603195
- Acronym / sponsor ID
- R7508-HV-21102
- Conditions
- Healthy Volunteer
- Keywords
- Thrombotic disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 2 Nov 2022 (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 study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.
This study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Lowest IV Dose | Experimental | Drug: REGN7508 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Cohort 2 Low IV Dose | Experimental | Drug: REGN7508 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Cohort 3 Mid IV Dose | Experimental | Drug: REGN7508 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Cohort 4 High IV Dose | Experimental | Drug: REGN7508 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Cohort 5 Higher IV Dose | Experimental | Drug: REGN7508 (IV), Drug: Matching Placebo (IV)Randomized 3:1 |
| Cohort 6 High SC Dose | Experimental | Drug: REGN7508 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
| Cohort 7 Higher SC Dose | Experimental | Drug: REGN7508 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
| Optional: Cohort 8 Highest IV or SC Dose | Experimental | Drug: REGN7508 (IV), Drug: REGN7508 (SC), Drug: Matching Placebo (IV), Drug: Matching Placebo (SC)Randomized 3:1 |
| Cohort 9 High SC Dose | Experimental | Drug: REGN7508 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
| Optional: Cohort 10 Highest SC Dose | Experimental | Drug: REGN7508 (SC), Drug: Matching Placebo (SC)Randomized 3:1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
- Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and echocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
- Participant is in good health based on laboratory safety testing obtained at the screening visit and/or prior to administration of initial dose of study drug
- Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT), and normal platelet counts at screening period and at the day -1 visit as defined by the local laboratory
- Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screening and day 1 visits
Key exclusion criteria (10 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 the screening visit
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation, as defined in the protocol
- Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening
- Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
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 |
|---|---|---|
| REGN7508 (IV)Administered sequential, ascending single intravenous (IV) dose | Drug | Cohort 1 Lowest IV Dose, Cohort 2 Low IV Dose, Cohort 3 Mid IV Dose, Cohort 4 High IV Dose, Cohort 5 Higher IV Dose, Optional: Cohort 8 Highest IV or SC Dose |
| REGN7508 (SC)Administered sequential, ascending single subcutaneous (SC) dose | Drug | Cohort 6 High SC Dose, Cohort 7 Higher SC Dose, Cohort 9 High SC Dose, Optional: Cohort 10 Highest SC Dose, Optional: Cohort 8 Highest IV or SC Dose |
| Matching Placebo (IV)Administered sequential, ascending single intravenous (IV) dose | Drug | Cohort 1 Lowest IV Dose, Cohort 2 Low IV Dose, Cohort 3 Mid IV Dose, Cohort 4 High IV Dose, Cohort 5 Higher IV Dose, Optional: Cohort 8 Highest IV or SC Dose |
| Matching Placebo (SC)Administered sequential, ascending single subcutaneous (SC) dose | Drug | Cohort 6 High SC Dose, Cohort 7 Higher SC Dose, Cohort 9 High SC Dose, Optional: Cohort 10 Highest SC Dose, Optional: Cohort 8 Highest IV or SC Dose |
Primary outcome
Incidences of treatment-emergent adverse events (TEAE)
Time frame: Up to 36 days
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Severity of TEAE
Time frame: Up to 36 days
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
7 secondary outcomes
Change from baseline in activated partial thromboplastin time (aPTT)
Time frame: Up to 36 days
Change from baseline in prothrombin time (PT)
Time frame: Up to 36 days
Concentrations of total REGN7508 in serum
Time frame: Up to 36 days
Concentrations of functional REGN7508 in plasma
Time frame: Up to 36 days
Absolute concentration and change from baseline in total Factor XI (FXI) concentrations
Time frame: Up to 36 days
Absolute concentration and change from baseline in free FXI concentrations
Time frame: Up to 36 days
Incidence of antidrug antibodies (ADAs) to REGN7508 over time
Time frame: Up to 36 days
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 1 Oct 2024.
- Derived from this study: PubMed 42275249Chalothorn D, Kithcart AP, Marin E, Somersan-Karakaya S, Lai K, Cauwberghs F, Ackroyd JPR, Mohammadi K, Shrestha A, Ehrlich GK, Rafique A, Chatterjee I, Saotome K, Franklin MC, Murphy AJ, Olson WC, Olenchock BA, Herman GA, Gutstein DE, Sirulnik A, Yancopoulos GD, Morton LG. Anticoagulation with mechanistically distinct FXI/FXIa antibodies amrecibart (REGN9933A2) and cenvacibart (REGN7508Cat). Blood. 2026 Jun 11:blood.2025032276. doi: 10.1182/blood.2025032276. Online ahead of print.
- 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 REGN7508 (IV) and REGN7508 (SC) in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
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 10 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 1 Oct 2024. 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 United Kingdom. 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?
Incidences of treatment-emergent adverse events (TEAE) (time frame: Up to 36 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?
On the ClinicalTrials.gov record for NCT05603195, which also lists 1 linked publication.
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 1 Oct 2024.