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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03735810 | Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses | PHASE1 | COMPLETED | 71 | — | — | Nov 15, 2018 | Sep 16, 2019 | Jan 7, 2020 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| SAD - Cohort 1 | EXPERIMENTAL | 50 mg LBS-008 or placebo |
| SAD - Cohort 2 | EXPERIMENTAL | 100 mg LBS-008 or placebo |
| SAD - Cohort 3 | EXPERIMENTAL | 200 mg LBS-008 or placebo |
| SAD - Cohort 4 | EXPERIMENTAL | 400 mg LBS-008 or placebo |
| SAD - Cohort 5 | EXPERIMENTAL | 25 mg LBS-008 or placebo |
| MAD - Cohort 1 | EXPERIMENTAL | 10 mg LBS-008 or placebo |
| MAD - Cohort 2 | EXPERIMENTAL | 25 mg LBS-008 or placebo |
| MAD - Cohort 3 | EXPERIMENTAL | 5 mg LBS-008 or placebo |
| MAD - Cohort 4 | EXPERIMENTAL | 12 mg LBS-008 or placebo |
| Name | Type | Description |
|---|---|---|
| LBS-008 | DRUG | LBS-008 oral capsules |
| Placebos | DRUG | Oral capsules |
Inclusion Criteria: * The subject is male or female, 18 to 65 years of age, inclusive, at screening. * The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. * The subject is willing and able to remain i...