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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05970718




Registration number
NCT05970718
Ethics application status
Date submitted
24/07/2023
Date registered
1/08/2023

Titles & IDs
Public title
A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants
Scientific 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
Secondary ID [1] 0 0
R7544-HV-22109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - REGN7544
Treatment: Drugs - Matching Placebo

Experimental: IV Dose Level 1 - Randomized 6:2 for single ascending IV dose

Experimental: IV Dose Level 2 - Randomized 6:2 for single ascending IV dose

Experimental: IV Dose Level 3 - Randomized 6:2 for single ascending IV dose

Experimental: IV Dose Level 4 - Randomized 6:2 for single ascending IV dose

Experimental: IV Dose Level 5 - Randomized 6:2 for single ascending IV dose

Experimental: IV Dose Level 6 - Randomized 6:2 for single ascending IV dose

Experimental: SC Dose Level 1 - Randomized 6:2 for single ascending SC dose

Experimental: SC Dose Level 2 - Randomized 6:2 for single ascending SC dose

Experimental: SC Dose Level 3 - Randomized 6:2 for single ascending SC dose

Experimental: Optional Cohort 1 - 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

Experimental: Optional Cohort 2 - 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


Treatment: Drugs: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Treatment: Drugs: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Through approximately day 162
Primary outcome [2] 0 0
Severity of TEAEs
Timepoint [2] 0 0
Through approximately day 162
Secondary outcome [1] 0 0
Changes from baseline in Systolic Blood Pressure (SBP)
Timepoint [1] 0 0
Through day 6
Secondary outcome [2] 0 0
Changes from baseline in Diastolic Blood Pressure (DBP)
Timepoint [2] 0 0
Through day 6
Secondary outcome [3] 0 0
Changes from baseline in Mean Arterial Pressure (MAP)
Timepoint [3] 0 0
Through day 6
Secondary outcome [4] 0 0
Changes from baseline in Pulse Pressure (PP)
Timepoint [4] 0 0
Through day 6
Secondary outcome [5] 0 0
Concentrations of REGN7544 in serum over time
Timepoint [5] 0 0
Through approximately day 162
Secondary outcome [6] 0 0
Incidence of treatment-emergent Anti-Drug Antibody (ADA)
Timepoint [6] 0 0
Through approximately day 162
Secondary outcome [7] 0 0
Titer of ADA
Timepoint [7] 0 0
Through approximately day 162

Eligibility
Key inclusion criteria
Key

1. Has a body mass index between 18 and 32 kg/m^2
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
3. Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
4. Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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
2. 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
3. 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
4. Was hospitalized (ie, >24 hours) for any reason within 30 days of screening
5. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2024
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05970718