Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

NCT02061358 ↗

Phase 1 Completed 64 enrolled Emergent BioSolutions Quintiles, Inc. · collab Unither Virology · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

Timeline

Start: 2014-07
Primary completion: 2015-07
Completion: 2015-09

Publications

Callahan M, Treston AM, Lin G, Smith M, Kaufman B, Khaliq M, Evans DeWald L, Spurgers K, Warfield KL, Lowe P, Duchars M, Sampath A, Ramstedt U. Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects. PLoS Negl Trop Dis. 2022 Aug 8;16(8):e0010636. doi: 10.1371/journal.pntd.0010636. eCollection 2022 Aug.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	UV-4	Small molecule	3 mg	Oral
Subject	UV-4	Small molecule	10 mg	Oral
Subject	UV-4	Small molecule	30 mg	Oral
Subject	UV-4	Small molecule	90 mg	Oral
Subject	UV-4	Small molecule	180 mg	Oral
Subject	UV-4	Small molecule	360 mg	Oral
Subject	UV-4	Small molecule	720 mg	Oral
Subject	UV-4	Small molecule	1000 mg	Oral

Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

Summary

Timeline

Publications

Drugs

Indications