NCT04818229

A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects

A Phase I, Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Positive-Controlled Study to Investigate the Effects of CBP-307 on the QTc Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Connect Biopharma Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.

Detailed description

This will be a Phase I, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, multi-site, 3-arm study to investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy male and female subjects.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	CBP-307	CBP-307 capsules oral administration.
DRUG	Placebo-matched CBP-307	Placebo-matched CBP-307 capsules oral administration.
DRUG	Moxifloxacin (Avelox)	Moxifloxacin tablets oral administration。
DRUG	Placebo-matched Moxifloxacin	Placebo-matched Moxifloxacin tablets oral administration.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-03-20
• Completion: 2022-03-30
• First posted: 2021-03-26
• Last updated: 2024-11-04
• Results posted: 2024-11-04

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study