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NCT03115996
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers
Phase 1 trial testing REGN3918 in Healthy Volunteers in 56 participants. Completed in 31 August 2018.
31 August 2018
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 56 |
| Start date | 10 May 2017 |
| Primary completion | 31 August 2018 |
| Estimated completion | 31 August 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- REGN3918 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
Adults 18 to 50, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
New insights into the immune functions of complement.
Reis ES, Mastellos DC, Hajishengallis G, Lambris JD. · · 2019 · cited 357× · PMID 31048789 · DOI 10.1038/s41577-019-0168-x -
The renaissance of complement therapeutics.
Ricklin D, Mastellos DC, Reis ES, Lambris JD. · · 2018 · cited 305× · PMID 29199277 · DOI 10.1038/nrneph.2017.156 -
Clinical promise of next-generation complement therapeutics.
Mastellos DC, Ricklin D, Lambris JD. · · 2019 · cited 255× · PMID 31324874 · DOI 10.1038/s41573-019-0031-6 -
Anti-complement Treatment for Paroxysmal Nocturnal Hemoglobinuria: Time for Proximal Complement Inhibition? A Position Paper From the SAAWP of the EBMT.
Risitano AM, Marotta S, Ricci P, Marano L, et al · · 2019 · cited 155× · PMID 31258525 · DOI 10.3389/fimmu.2019.01157 -
Complement System in Cutaneous Squamous Cell Carcinoma.
Riihilä P, Nissinen L, Knuutila J, Rahmati Nezhad P, et al · · 2019 · cited 29× · PMID 31331124 · DOI 10.3390/ijms20143550 -
Pharmacokinetics and pharmacodynamics of pozelimab alone or in combination with cemdisiran in non-human primates.
Devalaraja-Narashimha K, Huang C, Cao M, Chen YP, et al · · 2022 · cited 15× · PMID 35709087 · DOI 10.1371/journal.pone.0269749 -
Targeting complement cascade: an alternative strategy for COVID-19.
Ram Kumar Pandian S, Arunachalam S, Deepak V, Kunjiappan S, et al · · 2020 · cited 13× · PMID 33088671 · DOI 10.1007/s13205-020-02464-2 -
Association of complement pathways with COVID-19 severity and outcomes.
Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, et al · · 2023 · cited 9× · PMID 36494054 · DOI 10.1016/j.micinf.2022.105081
Verify or expand the search:
- PubMed search for NCT03115996
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of REGN3918
Trials testing the same drug.
- NCT04162470 — REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Toler · Phase 3 · terminated
- NCT03946748 — Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) · Phase 2 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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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 NCT03115996 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 26 September 2018
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/NCT03115996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing