A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes

Phase 1 Completed 103 enrolled MedImmune LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).

Timeline

Start: 2015-10-07
Primary completion: 2017-04-14
Completion: 2017-04-14

Publications

Jain M, Carlson G, Cook W, Morrow L, Petrone M, White NE, Wang T, Naylor J, Ambery P, Lee C, Hirshberg B. Randomised, phase 1, dose-finding study of MEDI4166, a PCSK9 antibody and GLP-1 analogue fusion molecule, in overweight or obese patients with type 2 diabetes mellitus. Diabetologia. 2019 Mar;62(3):373-386. doi: 10.1007/s00125-018-4789-6. Epub 2018 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MEDI-4166	Unknown	10 mg	Subcutaneous
Subject	MEDI-4166	Unknown	30 mg	Subcutaneous
Subject	MEDI-4166	Unknown	50 mg	Subcutaneous
Subject	MEDI-4166	Unknown	100 mg	Subcutaneous
Subject	MEDI-4166	Unknown	200 mg	Subcutaneous
Subject	MEDI-4166	Unknown	400 mg	Subcutaneous

A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes

Summary

Timeline

Publications

Drugs

Indications