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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05291546
Other study ID # R9035-HV-2125
Secondary ID 2021-005174-26
Status Completed
Phase Phase 1
First received
Last updated
Start date April 13, 2022
Est. completion date April 2, 2024

Study information

Verified date April 2024
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to: • Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially. The secondary objectives of the study are to: - Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381 - Evaluate the hemodynamic effects of single IV doses of REGN5381 - Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo) - Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date April 2, 2024
Est. primary completion date April 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Key Inclusion Criteria: 1. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit. 2. Normal or mildly elevated blood pressure as defined in the protocol. Key Exclusion Criteria: 1. History of unexplained syncope or autonomic dysfunction. 2. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease. 3. Protocol-defined risk factors for cardiovascular disease. Note: Other protocol defined inclusion / exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
REGN9035
Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22.
REGN5381
Part B: Selected doses administered by IV infusion on day 1.
Other:
Placebo
Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22.

Locations

Country Name City State
Belgium Universitair Ziekenhuis Leuven Gasthuisberg Campus Leuven
Germany Charite Research Organisation GmbH Berlin

Sponsors (1)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) Up to Day 162
Secondary Mean systolic blood pressure (SBP) obtained after study drug administration Up to 24 hours after study drug administration. Up to Day 3
Secondary Mean diastolic blood pressure (DBP) obtained after study drug administration Up to Day 3
Secondary Mean arterial pressure (MAP) obtained after study drug administration Up to Day 3
Secondary Mean pulse pressure (PP) obtained after study drug administration Up to Day 3
Secondary Mean pulse rate (PR) obtained after study drug administration Up to Day 3
Secondary Mean stroke volume (SV) obtained after study drug administration Up to Day 3
Secondary Absolute change in the mean SBP obtained after study drug administration Up to Day 3
Secondary Absolute change in the mean DBP obtained after study drug administration Up to Day 3
Secondary Absolute change in the mean MAP obtained after study drug administration Up to Day 3
Secondary Absolute change in the mean PP obtained after study drug administration Up to Day 3
Secondary Absolute change in the mean PR obtained after study drug administration Up to Day 3
Secondary Absolute change in the mean SV obtained after study drug administration Up to Day 3
Secondary Maximum change in the mean SBP obtained after study drug administration Up to Day 3
Secondary Maximum change in the mean DBP obtained after study drug administration Up to Day 3
Secondary Maximum change in the mean MAP obtained after study drug administration Up to Day 3
Secondary Maximum change in the mean PP obtained after study drug administration Up to Day 3
Secondary Maximum change in the mean PR obtained after study drug administration Up to Day 3
Secondary Maximum change in the mean SV obtained after study drug administration Up to Day 3
Secondary Percent change in the mean SBP obtained after study drug administration Up to Day 3
Secondary Percent change in the mean DBP obtained after study drug administration Up to Day 3
Secondary Percent change in the mean MAP obtained after study drug administration Up to Day 3
Secondary Percent change in the mean PP obtained after study drug administration Up to Day 3
Secondary Percent change in the mean PR obtained after study drug administration Up to Day 3
Secondary Percent change in the mean SV obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (post-REN5381 administration) in the mean SV obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (pre-REGN5381 administration) in the mean SBP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (pre-REGN5381 administration) in the mean DBP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (pre-REGN5381 administration) in the mean MAP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (pre-REGN5381 administration) in the mean PP obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (pre-REGN5381 administration) in the mean PR obtained after study drug administration Up to Day 3
Secondary Absolute change from baseline (pre-REGN5381 administration) in the mean SV obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (pre-REGN administration) in the mean SBP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (pre-REGN administration) in the mean DBP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (pre-REGN administration) in the mean MAP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (pre-REGN administration) in the mean PP obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (pre-REGN administration) in the mean PR obtained after study drug administration Up to Day 3
Secondary Maximum change from baseline (pre-REGN administration) in the mean SV obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (pre-REN5381 administration) in the mean SBP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (pre-REN5381 administration) in the mean DBP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (pre-REN5381 administration) in the mean MAP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (pre-REN5381 administration) in the mean PP obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (pre-REN5381 administration) in the mean PR obtained after study drug administration Up to Day 3
Secondary Percent change from baseline (pre-REN5381 administration) in the mean SV obtained after study drug administration Up to Day 3
Secondary Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SBP obtained after study drug administration. Baseline to Day 3
Secondary Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) DBP obtained after study drug administration. Baseline to Day 3
Secondary Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) MAP obtained after study drug administration. Baseline to Day 3
Secondary Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PP obtained after study drug administration. Baseline to Day 3
Secondary Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PR obtained after study drug administration. Baseline to Day 3
Secondary Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SV obtained after study drug administration. Baseline to Day 3
Secondary Time to return to within 10% of baseline (pre-REGN5381) SBP Up to approximately Day 162
Secondary Time to return to within 10% of baseline (pre-REGN5381) DBP Up to approximately Day 162
Secondary Time to return to within 10% of baseline (pre-REGN5381) MAP Up to approximately Day 162
Secondary Time to return to within 10% of baseline (pre-REGN5381) PP Up to approximately Day 162
Secondary Time to return to within 10% of baseline (pre-REGN5381) PR Up to approximately Day 162
Secondary Time to return to within 10% of baseline (pre-REGN5381) SV Up to approximately Day 162
Secondary SBP Through Day 36
Secondary DBP Through Day 36
Secondary MAP Through Day 36
Secondary PP Through Day 36
Secondary PR Through Day 36
Secondary Absolute change from baseline in SBP Through Day 36
Secondary Absolute change from baseline in DBP Through Day 36
Secondary Absolute change from baseline in MAP Through Day 36
Secondary Absolute change from baseline in PP Through Day 36
Secondary Absolute change from baseline in PR Through Day 36
Secondary Percent change from baseline in SBP Through Day 36
Secondary Percent change from baseline in DBP Through Day 36
Secondary Percent change from baseline in MAP Through Day 36
Secondary Percent change from baseline in PP Through Day 36
Secondary Percent change from baseline in PR Through Day 36
Secondary Concentrations of total REGN9035 Up to Day 162
Secondary Concentrations of total REGN5381 over time Up to Day 162
Secondary Concentrations of total REGN9035 and/or total REGN5381 Up to Day 162
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