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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03838185 | Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147 | PHASE1 | COMPLETED | 64 | — | — | Jan 22, 2019 | Feb 1, 2020 | Sep 3, 2020 | 1 | United States |
Nature, frequency and severity of adverse events
12-lead electrocardiogram measurement
Changes in standard serum chemistry measures will be assessed.
Changes in standard hematology measures will be assessed.
Changes in standard urinalysis measures will be assessed.
| Arm | Type | Description |
|---|---|---|
| Study Drug | EXPERIMENTAL | Healthy young male subjects will receive a single ascending oral dose of J147 following an overnight fast of at least 8 hours. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive a single oral dose of placebo with 240 mL non-carbonated water in the morning following an overnight fast of at least 8 hours. |
| Name | Type | Description |
|---|---|---|
| J147 | DRUG | Single oral dose of J147 |
| Placebo | DRUG | Single oral dose of corn oil |
Inclusion Criteria: * Provide voluntarily agreement to participate in this study and signs an IRB/IEC-approved informed consent prior to performing any of the screening procedures * Healthy male subjects, between 18 to 50 years of age, inclusive, at the time of signing the informed consent; OR, Hea...