Healthy VolunteersPhase 1NCT05970718
A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants
A Phase 1 study testing REGN7544 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in New Zealand.
Trial summary
The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN7544
- 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 siteNew Zealand
- Study dates
- 7 Aug 2023to 22 Jul 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
- Has a body mass index between 18 and 32 kg/m^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, as defined in the protocol
- Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
- Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological 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
- History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (BP <90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia
- 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
- Was hospitalized (ie, >24 hours) for any reason within 30 days of screening
- Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening
- 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 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7544, an Antagonistic Monoclonal Antibody to NPR1, in Healthy Adults
The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.
The 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 your 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 Volunteers
- Being tested
- REGN7544, Matching Placebo
- Keywords
- Hypotension and/or hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7544Drug
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration
Matching PlaceboDrug
Solution for single ascending IV or SC administration per the protocol
| Study group | Role | What they receive |
|---|---|---|
| IV Dose Level 1 | Experimental | Randomized 6:2 for single ascending IV dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| IV Dose Level 2 | Experimental | Randomized 6:2 for single ascending IV dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| IV Dose Level 3 | Experimental | Randomized 6:2 for single ascending IV dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| IV Dose Level 4 | Experimental | Randomized 6:2 for single ascending IV dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| IV Dose Level 5 | Experimental | Randomized 6:2 for single ascending IV dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| IV Dose Level 6 | Experimental | Randomized 6:2 for single ascending IV dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| SC Dose Level 1 | Experimental | Randomized 6:2 for single ascending SC dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| SC Dose Level 2 | Experimental | Randomized 6:2 for single ascending SC dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| SC Dose Level 3 | Experimental | Randomized 6:2 for single ascending SC dose Receives: Drug: REGN7544; Drug: Matching Placebo |
| Optional Cohort 1 | Experimental | Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level Receives: Drug: REGN7544; Drug: Matching Placebo |
| Optional Cohort 2 | Experimental | Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level Receives: Drug: REGN7544; 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: Through approximately day 162
Severity of TEAEs
Measured: Through approximately day 162
Secondary outcomes (7)
Changes from baseline in Systolic Blood Pressure (SBP)
Measured: Through day 6
Changes from baseline in Diastolic Blood Pressure (DBP)
Measured: Through day 6
Changes from baseline in Mean Arterial Pressure (MAP)
Measured: Through day 6
Changes from baseline in Pulse Pressure (PP)
Measured: Through day 6
Concentrations of REGN7544 in serum over time
Measured: Through approximately day 162
Incidence of treatment-emergent Anti-Drug Antibody (ADA)
Measured: Through approximately day 162
Titer of ADA
Measured: Through approximately day 162
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start7 Aug 2023
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- NCT05970718
- Sponsor's protocol ID
- R7544-HV-22109
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 12 Aug 2024. 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 REGN7544, an Antagonistic Monoclonal Antibody to NPR1, in Healthy Adults
- ClinicalTrials.gov ID
- NCT05970718
- Acronym / sponsor ID
- R7544-HV-22109
- Conditions
- Healthy Volunteers
- Keywords
- Hypotension and/or hypovolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 1 Aug 2023 (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.
The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.
The 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 your 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
- 11
| Arm | Type | Receives |
|---|---|---|
| IV Dose Level 1 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending IV dose |
| IV Dose Level 2 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending IV dose |
| IV Dose Level 3 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending IV dose |
| IV Dose Level 4 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending IV dose |
| IV Dose Level 5 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending IV dose |
| IV Dose Level 6 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending IV dose |
| SC Dose Level 1 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending SC dose |
| SC Dose Level 2 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending SC dose |
| SC Dose Level 3 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending SC dose |
| Optional Cohort 1 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level |
| Optional Cohort 2 | Experimental | Drug: REGN7544, Drug: Matching PlaceboRandomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has a body mass index between 18 and 32 kg/m^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, as defined in the protocol
- Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
- Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit
Key exclusion criteria (6 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological 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
- History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (BP <90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia
- 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
- Was hospitalized (ie, >24 hours) for any reason within 30 days of screening
- Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening
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 |
|---|---|---|
| REGN7544Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration | Drug | IV Dose Level 1, IV Dose Level 2, IV Dose Level 3, IV Dose Level 4, IV Dose Level 5, IV Dose Level 6, Optional Cohort 1, Optional Cohort 2, SC Dose Level 1, SC Dose Level 2, SC Dose Level 3 |
| Matching PlaceboSolution for single ascending IV or SC administration per the protocol | Drug | IV Dose Level 1, IV Dose Level 2, IV Dose Level 3, IV Dose Level 4, IV Dose Level 5, IV Dose Level 6, Optional Cohort 1, Optional Cohort 2, SC Dose Level 1, SC Dose Level 2, SC Dose Level 3 |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through approximately day 162
Severity of TEAEs
Time frame: Through approximately day 162
7 secondary outcomes
Changes from baseline in Systolic Blood Pressure (SBP)
Time frame: Through day 6
Changes from baseline in Diastolic Blood Pressure (DBP)
Time frame: Through day 6
Changes from baseline in Mean Arterial Pressure (MAP)
Time frame: Through day 6
Changes from baseline in Pulse Pressure (PP)
Time frame: Through day 6
Concentrations of REGN7544 in serum over time
Time frame: Through approximately day 162
Incidence of treatment-emergent Anti-Drug Antibody (ADA)
Time frame: Through approximately day 162
Titer of ADA
Time frame: Through approximately day 162
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 12 Aug 2024.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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 REGN7544 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in New Zealand.
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 4 inclusion and 6 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 12 Aug 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 New Zealand. 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: Through approximately day 162). 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 12 Aug 2024.