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Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD Effects in Male Volunteers

IBD Clinical Trial

Official title:
Phase 1a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of AKB 4924 in Healthy Male Volunteers

Clinical Trial Summary

This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.

Clinical Trial Description

Single oral doses of AKB-4924 will be investigated in up to 6 sequential cohorts of 8 healthy male subjects. Primarily 6 dose levels are planned; the proposed doses are 20 mg, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg. Actual doses may be decreased or increased based on the safety and tolerability of the drug, as determined by the Investigator and Sponsor. Additional cohorts may be added as needed to test lower, higher, or repeat doses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02914262
Study type Interventional
Source Aerpio Therapeutics
Contact
Status Completed
Phase Phase 1
Start date August 2016
Completion date January 2017
View Details
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