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NCT04616079
Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers
Phase 1 trial testing REGN6490 in Healthy Volunteer in 57 participants. Terminated before completion.
1 June 2021
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 57 |
| Start date | 19 November 2020 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- REGN6490 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteer. 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 single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants The secondary objectives of the study are to: * Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants * Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04616079
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of REGN6490
Trials testing the same drug.
- NCT04616105 — Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers · Phase 1 · terminated
Other recruiting trials for Healthy Volunteer
Currently open trials in the same condition.
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- NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
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Other Regeneron Pharmaceuticals trials
Trials by the same sponsor.
- NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
- NCT07526116 — A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adul · Phase 1 · not yet recruiting
- NCT07527923 — First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis · Phase 1 · not yet recruiting
- NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
- NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · not yet recruiting
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 NCT04616079 (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: 11 November 2021
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/NCT04616079.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing