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NCT04818229 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
A Phase 1 study of Autoimmune Diseases, sponsored by Connect Biopharma Australia Pty.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
- 2
- Study locations
NCT04818229: Completed Phase 1 study of Autoimmune Diseases, sponsored by Connect Biopharma Australia Pty.
NCT04818229 is a Phase 1 study of Autoimmune Diseases that has completed, run by Connect Biopharma Australia Pty. The registered enrollment target is 112 participants, below the 974-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04818229, a Phase 1 study of Autoimmune Diseases, has completed, sponsored by Connect Biopharma Australia Pty.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
Primary Outcome
Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.
Conditions Studied
Interventions
- DRUG CBP-307
- DRUG Placebo-matched CBP-307
- DRUG Moxifloxacin (Avelox)
- DRUG Placebo-matched Moxifloxacin
Study Locations (2)
Florida
- Clinical Pharmacology of Miami (CPMI), LLC - Hialeah
South Australia
- CMAX - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 1 |
What the finished NCT04818229 record still lists
NCT04818229 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 974-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Autoimmune Diseases appearing as the primary indexed condition, and to 4 interventions - of which CBP-307 is the first listed.
NCT04818229 reports a single indexed study location in Florida, South Australia.
Frequently Asked Questions
What is clinical trial NCT04818229 about?
NCT04818229 is a clinical study titled "A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects". This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
What is the current status of trial NCT04818229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2021-06-01. Estimated completion is 2022-03-30.
What conditions does trial NCT04818229 study?
This clinical trial studies the following conditions: Autoimmune Diseases.
What interventions are being tested in trial NCT04818229?
The interventions under investigation include: CBP-307 (DRUG), Placebo-matched CBP-307 (DRUG), Moxifloxacin (Avelox) (DRUG), Placebo-matched Moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT04818229?
This trial is sponsored by Connect Biopharma Australia Pty, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04818229 being conducted?
This trial has 2 study locations across Florida, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04818229's enrollment target sits among peer trials
112 14th of 25 higher than 12 of 25 other Autoimmune Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autoimmune Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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