HealthyPhase 1NCT04506645
Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult Humans
A Phase 1 study testing REGN5381 in people with Healthy, run by Regeneron Pharmaceuticals at 2 sites in Belgium.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive 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
- What is being tested?
- REGN5381
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2020to 14 Dec 2022
- 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
- 1. Normal or mildly elevated blood pressure as defined in the protocol
Who cannot join
- History of cardiovascular disease as defined in the protocol
- Protocol-defined risk factors for cardiovascular disease
- History of unexplained syncope, autonomic dysfunction, or neurologic disease.
- NOTE: Additional Inclusion / Exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University
Ghent, 9000
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, B-3000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Humans
The primary objective of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive adults.
The secondary objectives of the study are:
- To evaluate the effect of single IV doses of REGN5381 on blood pressure (BP) and heart rate (HR) in healthy normotensive and otherwise healthy hypertensive adults
- To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume (SV)
- To evaluate the pharmacokinetics (PK) of single IV doses of REGN5381
- To evaluate the immunogenicity of single IV doses of REGN5381
- Conditions
- Healthy
- Being tested
- REGN5381, Placebo
- Keywords
- Normal Blood Pressure (BP), Mildly Elevated BP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5381Drug
Single dose REGN5381 administered via IV infusion
PlaceboOther
Placebo matching single dose REGN 5381 administered via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| REGN5381 | Experimental | Single dose REGN5381 administered via IV infusion Receives: Drug: REGN5381 |
| Placebo | Other | Placebo matching single dose REGN 5381 administered via IV infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: Up to Day 78
Secondary outcomes (20)
Change from baseline in Systolic Blood Pressure (SBP)
Measured: Up to Day 78
Change from baseline in Diastolic Blood Pressure (DBP)
Measured: Up to Day 78
Change from baseline in Mean Arterial Pressure (MAP)
Measured: Baseline to Day 4
Change from baseline in Pulse Pressure (PP)
Measured: Baseline to Day 4
Change from baseline in Heart Rate (HR)
Measured: Up to Day 78
Change from baseline in Stroke Volume (SV)
Measured: Baseline to Day 4
Maximum change from baseline in SBP across the first 24 hours postdose
Measured: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in DBP across the first 24 hours postdose
Measured: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in MAP across the first 24 hours postdose
Measured: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in PP across the first 24 hours postdose
Measured: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in HR across the first 24 hours postdose
Measured: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in SV across the first 24 hours postdose
Measured: Baseline to Day 2 (24-hours post dose)
Change from baseline in the 24-hour mean SBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Baseline 24-hour mean SBP is measured from 0 to 24 hours pre-dose
Measured: Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose
Change from baseline in the 24-hour mean DBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Baseline 24-hour mean DBP is measured from 0 to 24 hours pre-dose
Measured: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Change from baseline in the 24-hour mean MAP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Baseline 24-hour mean MAP is measured from 0 to 24 hours pre-dose
Measured: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Change from baseline in the 24-hour mean PP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Baseline 24-hour mean PP is measured from 0 to 24 hours pre-dose
Measured: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Change from baseline in the 24-hour mean HR measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Baseline 24-hour mean HR is measured from 0 to 24 hours pre-dose
Measured: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Concentrations of REGN5381 over time
Measured: Up to Day 78
Number of subjects who develop anti-drug antibodies (ADA) and titers
Measured: Up to Day 78
Percentage of subjects who develop anti-drug antibodies (ADA) and titers
Measured: Up to Day 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2020
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 90 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
- NCT04506645
- Sponsor's protocol ID
- R5381-HV-1987
- Other IDs
- 2020-000940-75
- Status last verified
- Dec 2022
- First submitted
- 28 Jul 2020
- Last updated
- 20 Dec 2022
- Results posted
- 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 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Humans
- ClinicalTrials.gov ID
- NCT04506645
- Acronym / sponsor ID
- R5381-HV-1987
- Conditions
- Healthy
- Keywords
- Normal Blood Pressure (BP), Mildly Elevated BP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 10 Aug 2020 (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 primary objective of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive adults.
The secondary objectives of the study are:
- To evaluate the effect of single IV doses of REGN5381 on blood pressure (BP) and heart rate (HR) in healthy normotensive and otherwise healthy hypertensive adults
- To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume (SV)
- To evaluate the pharmacokinetics (PK) of single IV doses of REGN5381
- To evaluate the immunogenicity of single IV doses of REGN5381
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN5381 | Experimental | Drug: REGN5381Single dose REGN5381 administered via IV infusion |
| Placebo | Other | Other: PlaceboPlacebo matching single dose REGN 5381 administered via IV infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Normal or mildly elevated blood pressure as defined in the protocol
Key exclusion criteria (4 listed)
- History of cardiovascular disease as defined in the protocol
- Protocol-defined risk factors for cardiovascular disease
- History of unexplained syncope, autonomic dysfunction, or neurologic disease.
- NOTE: Additional Inclusion / Exclusion criteria apply
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 |
|---|---|---|
| REGN5381Single dose REGN5381 administered via IV infusion | Drug | REGN5381 |
| PlaceboPlacebo matching single dose REGN 5381 administered via IV infusion | Other | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to Day 78
20 secondary outcomes
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Up to Day 78
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Up to Day 78
Change from baseline in Mean Arterial Pressure (MAP)
Time frame: Baseline to Day 4
Change from baseline in Pulse Pressure (PP)
Time frame: Baseline to Day 4
Change from baseline in Heart Rate (HR)
Time frame: Up to Day 78
Change from baseline in Stroke Volume (SV)
Time frame: Baseline to Day 4
Maximum change from baseline in SBP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in DBP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in MAP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in PP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in HR across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in SV across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Change from baseline in the 24-hour mean SBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Time frame: Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose
Change from baseline in the 24-hour mean DBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Change from baseline in the 24-hour mean MAP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Change from baseline in the 24-hour mean PP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Change from baseline in the 24-hour mean HR measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Concentrations of REGN5381 over time
Time frame: Up to Day 78
Number of subjects who develop anti-drug antibodies (ADA) and titers
Time frame: Up to Day 78
Percentage of subjects who develop anti-drug antibodies (ADA) and titers
Time frame: Up to Day 78
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 20 Dec 2022.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN5381 in people with Healthy, run by Regeneron Pharmaceuticals at 2 sites 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 1 inclusion and 4 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (time frame: Up to Day 78). 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 20 Dec 2022.