drugset / Trial / NCT01749878
Study to Assess the Safety and Tolerability of Single Doses of REGN1500
RandomizedSingle-groupTriple-blindTreatment
Summary
Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of REGN1500
Timeline
- Start
- 2012-12
- Primary completion
- 2016-01
- Completion
- 2016-01
Publications
- Ahmad Z, Banerjee P, Hamon S, Chan KC, Bouzelmat A, Sasiela WJ, Pordy R, Mellis S, Dansky H, Gipe DA, Dunbar RL. Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia. Circulation. 2019 Aug 6;140(6):470-486. doi: 10.1161/CIRCULATIONAHA.118.039107. Epub 2019 Jun 27.
- Dewey FE, Gusarova V, Dunbar RL, O'Dushlaine C, Schurmann C, Gottesman O, McCarthy S, Van Hout CV, Bruse S, Dansky HM, Leader JB, Murray MF, Ritchie MD, Kirchner HL, Habegger L, Lopez A, Penn J, Zhao A, Shao W, Stahl N, Murphy AJ, Hamon S, Bouzelmat A, Zhang R, Shumel B, Pordy R, Gipe D, Herman GA, Sheu WHH, Lee IT, Liang KW, Guo X, Rotter JI, Chen YI, Kraus WE, Shah SH, Damrauer S, Small A, Rader DJ, Wulff AB, Nordestgaard BG, Tybjaerg-Hansen A, van den Hoek AM, Princen HMG, Ledbetter DH, Carey DJ, Overton JD, Reid JG, Sasiela WJ, Banerjee P, Shuldiner AR, Borecki IB, Teslovich TM, Yancopoulos GD, Mellis SJ, Gromada J, Baras A. Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease. N Engl J Med. 2017 Jul 20;377(3):211-221. doi: 10.1056/NEJMoa1612790. Epub 2017 May 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evinacumab | Monoclonal antibody | 5 mg/kg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 10 mg/kg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 20 mg/kg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 250 mg | Subcutaneous |