Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04818229 | A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects | PHASE1 | COMPLETED | 112 | — | — | Jun 1, 2021 | Mar 30, 2022 | Nov 4, 2024 | 2 | United States, Australia |
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.
| Arm | Type | Description |
|---|---|---|
| Investigational Group 1 | EXPERIMENTAL | Therapeutic and supratherapeutic multiple oral doses of CBP-307. |
| Investigational Group 2A | PLACEBO_COMPARATOR | Moxifloxacin (positive control for method validation) and Placebo oral administration. |
| Investigational Group 2B | PLACEBO_COMPARATOR | Moxifloxacin (positive control for method validation) and Placebo oral administration. |
| Name | Type | Description |
|---|---|---|
| CBP-307 | DRUG | CBP-307 capsules oral administration. |
| Placebo-matched CBP-307 | DRUG | Placebo-matched CBP-307 capsules oral administration. |
| Moxifloxacin (Avelox) | DRUG | Moxifloxacin tablets oral administration。 |
| Placebo-matched Moxifloxacin | DRUG | Placebo-matched Moxifloxacin tablets oral administration. |
Inclusion Criteria: 1. Males or females, of any race, between 18 and 60 years of age, inclusive. 2. Body mass index between 18.0 and 30.0 kg/mE2, inclusive. 3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measu...