NCT02914262

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aerpio Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• IBD

Interventions

Type	Name	Description
DRUG	AKB-4924	Comparison of different dosages of AKB-4924
OTHER	Placebo	Placebo comparator

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2016-09-26
• Last updated: 2017-03-16

Locations

1 site across 1 country: Canada