NCT05291546CompletedPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects
Source: ClinicalTrials.gov · Last updated 15 Apr 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 28 Feb 2022
- Start date
- 13 Apr 2022
- Primary completion date
- 2 Apr 2024
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- High blood pressure
- NCT number
- NCT05291546
- EudraCT number
- 2021-005174-26
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 93
- From 13 Apr 2022 to the primary completion date, 2 Apr 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of unexplained syncope or autonomic dysfunction.
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
- Protocol-defined risk factors for cardiovascular disease.
- Note: Other protocol defined inclusion / exclusion criteria apply
Who the study is looking for
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
- Normal or mildly elevated blood pressure as defined in the protocol.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Leuven Gasthuisberg Campus Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.