NCT02280434

Phase 1 Study Accessing the Safety and Tolerability of CBP-307

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CBP-307 Following Oral Single and Multiple Escalating Dose Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects.

Detailed description

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects. The study will have two parts: Part 1 will assess 5 dose levels of the drug in single dosing; and Part 2 will evaluate 3 dose levels in 28-day repeat dosing. The effect of food will also be evaluated in a single dosing study.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	CBP-307
DRUG	Placebo

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-10-31
• Last updated: 2016-11-03

Locations

1 site across 1 country: Australia