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NCT03115996

Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers

Completed Phase 1 Last updated 26 September 2018
What this trial tests

Phase 1 trial testing REGN3918 in Healthy Volunteers in 56 participants. Completed in 31 August 2018.

Timeline
10 May 2017
Primary endpoint
31 August 2018
31 August 2018

Quick facts

Lead sponsorRegeneron Pharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposebasic science
Enrollment56
Start date10 May 2017
Primary completion31 August 2018
Estimated completion31 August 2018
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. The renaissance of complement therapeutics.
    Ricklin D, Mastellos DC, Reis ES, Lambris JD. · · 2018 · cited 305× · PMID 29199277 · DOI 10.1038/nrneph.2017.156
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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

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Data sources for this page

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