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Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial.
Robbins JA, Tait D, Huang Q, Dubey S, Crumley T, Cote J, Luk J, Sachs JR, Rutkowski K, Park H, Schwab R, Howitt WJ, Rondon JC, Hernandez-Illas M, O'Reilly T, Smith W, Simon J, Hardalo C, Zhao X, Wnek R, Cope A, Lai E, Annunziato P, Guris D, Stoch SA. Robbins JA, et al. EBioMedicine. 2022 Aug;82:104138. doi: 10.1016/j.ebiom.2022.104138. Epub 2022 Jul 6. EBioMedicine. 2022. PMID: 35809371 Free PMC article. Clinical Trial.
A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.
Bellon A, Wang J, Skerjanec A, Velinova M, Dickerson D, Sabet A, Ngo L, O'Reilly T, Tomek C, Schussler S, Schier-Mumzhiu S, Gattu S, Koch SD, Schelcher C, Dobreva M, Boldea A, Nakov R, Otto GP. Bellon A, et al. Br J Clin Pharmacol. 2020 Jun;86(6):1139-1149. doi: 10.1111/bcp.14226. Epub 2020 Feb 21. Br J Clin Pharmacol. 2020. PMID: 32022282 Free PMC article. Clinical Trial.
First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers.
Fox JC, Hellawell JL, Rao S, O'Reilly T, Lumpkin R, Jernelius J, Gretler D, Sinha U. Fox JC, et al. Clin Pharmacol Drug Dev. 2020 Jan;9(1):115-129. doi: 10.1002/cpdd.700. Epub 2019 Jun 6. Clin Pharmacol Drug Dev. 2020. PMID: 31172685 Free PMC article. Clinical Trial.
165 results