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NCT05291546
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
Phase 1 trial testing REGN9035 in Healthy Volunteers in 93 participants. Completed in 2 April 2024.
2 April 2024
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 93 |
| Start date | 13 April 2022 |
| Primary completion | 2 April 2024 |
| Estimated completion | 2 April 2024 |
| Sites | 2 locations across Belgium, Germany |
Drugs / interventions tested
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05291546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Regeneron Pharmaceuticals trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05291546 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
- Last refreshed: 15 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05291546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing