Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

Timeline

Start

2019-08-11

Primary completion

2022-01-30

Completion

2022-04-30

Drugs

Indications