NCT04811469

Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-174 After Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Connect Biopharma Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of CBP-174 after a single oral dose in healthy adult subjects.

Detailed description

This is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of CBP-174 compared to placebo. The study plans to set 6 dose escalation cohorts with single oral dose. Each subject will receive only one dose regimen in this study and the total duration to participate the study is approximately 1 to 4-week.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	CBP-174	CBP-174 oral solution, given once
DRUG	Placebo	Placebo oral solution, given once

Timeline

• Start date: 2021-05-24
• Primary completion: 2022-05-14
• Completion: 2022-05-21
• First posted: 2021-03-23
• Last updated: 2022-08-10

Locations

1 site across 1 country: Australia