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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06558097 | Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants | PHASE1 | COMPLETED | 77 | — | — | Jul 29, 2020 | Mar 31, 2023 | Aug 16, 2024 | 1 | United States |
To evaluate the safety and tolerability of single ascending SC doses of XXB750 in healthy participants. Adverse events may include abnormal vital signs, safety laboratory tests, physical exam tests and ECG parameters that include clinical signs or symptoms, are considered clinically significant or require therapy.
| Arm | Type | Description |
|---|---|---|
| XXB750 s.c 1 mg | EXPERIMENTAL | Single SC dose of XXB750 1 mg |
| XXB750 s.c 3 mg | EXPERIMENTAL | Single SC dose of XXB750 3 mg |
| XXB750 s.c 10 mg | EXPERIMENTAL | Single SC dose of XXB750 10 mg |
| XXB750 s.c 30 mg | EXPERIMENTAL | Single SC dose of XXB750 30 mg |
| XXB750 s.c 60 mg | EXPERIMENTAL | Single SC dose of XXB750 60 mg |
| XXB750 s.c 120 mg | EXPERIMENTAL | Single SC dose of XXB750 120 mg |
| XXB750 s.c 240 mg | EXPERIMENTAL | Single SC dose of XXB750 240 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo to XXB750 |
| XXB750 s.c 240 mg Japanese cohort | EXPERIMENTAL | Single SC dose of XXB750 240 mg in the Japanese cohort |
| Placebo for Japanese cohort | PLACEBO_COMPARATOR | Placebo to XXB750 in the Japanese cohort |
| XXB750 s.c 450 mg (HBP) | EXPERIMENTAL | Single SC dose of XXB750 450 mg (High Blood Pressure Cohort) |
| XXB750 s.c 600 mg (HBP) | EXPERIMENTAL | Single SC dose of XXB750 600 mg (High Blood Pressure Cohort) |
| Placebo to High Blood Pressure cohort | PLACEBO_COMPARATOR | Placebo to XXB750 in High Blood Pressure cohorts |
| Name | Type | Description |
|---|---|---|
| XXB750 | DRUG | Single SC dose of XXB750 (administered by single or multiple injections) |
| Placebo | OTHER | Single SC dose of matching placebo (administered by single or multiple injections) |
Inclusion Criteria: * Healthy male and female participants age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * Participants must weigh at least 50 kg to participate i...