Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CBP-307 · 3 trials · 2 indications
Ratio of total radioactivity in whole blood to that in plasma
Percentage of each metabolite in urine and feces to the administered dose (% of administered dose) or percentage of circulating metabolites in plasma to total exposure AUC (% AUC)
Ratio of total radioactivity in whole blood to that in plasma
Ratio of total radioactivity in whole blood to that in plasma
Ratio of total radioactivity in whole blood to that in plasma
Ratio of total radioactivity in whole blood to that in plasma
Ratio of total radioactivity in whole blood to that in plasma
Ratio of total radioactivity in whole blood to that in plasma
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.
Safety measurements will include vital signs, hematology, blood chemistry, blood pressure and other readouts.
| Arm | Type | Description |
|---|---|---|
| CBP-307 | EXPERIMENTAL | Take CBP-307orally at 30 min ± 2 min after the start of high-fat breakfast intake |
| 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. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose or once daily dose of matching placebo for 28 days. |
| 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. |
| Placebo | DRUG | - |
Inclusion Criteria: 1. A healthy male adult 2. Age: 18 to 45 years old (inclusive) 3. Weight: body mass index (BMI) is between 19 and 26 kg/m2(inclusive), and weight of no less than 50 kg 4. Subjects who are willing to sign Informed Consent Form 5. Subjects should be able to communicate well with t...
CBP-307 is an investigational small molecule being developed for autoimmune diseases, including moderate to severe ulcerative colitis. It has been studied in healthy adult subjects as well. The drug is in clinical development and is not approved by the FDA.
CBP-307 is being developed by Connect Biopharma Holdings Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNTB. The company has conducted clinical trials of CBP-307 in multiple countries.
CBP-307 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial evaluated the drug in patients with moderate to severe ulcerative colitis. CBP-307 remains investigational and is not FDA approved.
CBP-307 has been studied in several completed trials, including NCT02280434 (Phase 1 safety and tolerability in autoimmune diseases), NCT04700449 (Phase 2 efficacy and safety in ulcerative colitis), NCT04818229 (Phase 1 QT interval study), and NCT05040113 (Phase 1 mass balance study).
CBP-307 is a distinct investigational small molecule developed by Connect Biopharma. No alternative names for CBP-307 have been reported in the clinical trial data.