Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male Subjects

Summary

The first-in-man study are designed as below to assess safety, tolerability, and preliminary pharmacokinetics of ZL-2102. * Double-blind randomized, placebo-controlled ascending single oral doses (Part 1, ZL-2102-SAD); * Open-label, randomized, 2-sequence, 2-period, 2-treatment crossover (Part 2, ZL-2102-FED); * Double-blind randomized, placebo-controlled, ascending repeated oral doses for 14 days (Part 3, ZL-2102-MAD). A total of 104 subjects will be enrolled.

Timeline

Start

2015-03

Primary completion

2016-04

Completion

2019-08

Drugs

Indications