Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.

Phase 1 Completed 16 enrolled Hivih Venn Life Sciences · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated.

Timeline

Start: 2018-05-17
Primary completion: 2018-08-13
Completion: 2018-08-28

Publications

Bonnard D, Le Rouzic E, Singer MR, Yu Z, Le Strat F, Batisse C, Batisse J, Amadori C, Chasset S, Pye VE, Emiliani S, Ledoussal B, Ruff M, Moreau F, Cherepanov P, Benarous R. Biological and Structural Analyses of New Potent Allosteric Inhibitors of HIV-1 Integrase. Antimicrob Agents Chemother. 2023 Jul 18;67(7):e0046223. doi: 10.1128/aac.00462-23. Epub 2023 Jun 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BDM-2	Small molecule	50 mg	Oral
Subject	BDM-2	Small molecule	3600 mg	Oral

Indications

No indication recorded.