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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06425861 | A First in Human Trial Evaluating THB335 in Healthy Participants | PHASE1 | COMPLETED | 60 | — | — | May 2, 2024 | Dec 18, 2024 | Dec 19, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| THB335 single dose | EXPERIMENTAL | Single dose of THB335 fasted |
| THB335 fasted and fed | EXPERIMENTAL | Single dose of THB335 fasted and then fed |
| THB335 multiple dose | EXPERIMENTAL | 14 days of multiple ascending doses of THB335 |
| Single dose placebo | PLACEBO_COMPARATOR | Single dose of placebo capsule, fasted |
| Fasted and fed placebo | PLACEBO_COMPARATOR | Single dose of placebo capsule fasted and then fed |
| Multiple dose placebo | PLACEBO_COMPARATOR | 14 days of multiple doses of placebo capsule |
| Name | Type | Description |
|---|---|---|
| THB335 single dose | DRUG | Single dose as oral capsule |
| Single dose placebo | DRUG | Single dose as oral capsule |
| THB335 fasted/fed | DRUG | Single dose fasted and fed as oral capsule |
| Placebo fasted/fed | DRUG | Single dose fasted and fed as oral capsule |
| THB335 multiple dose | DRUG | Multiple ascending doses oral capsule |
| Multiple dose placebo | DRUG | Multiple doses oral capsule |
Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations * Males or females, of any race, between 18 and 65 years of age, inclusive. * Participants must ...