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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04309526 | Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects | PHASE1 | COMPLETED | 48 | — | — | Mar 18, 2020 | Oct 13, 2020 | Nov 3, 2020 | 1 | United States |
An adverse event is defined as any untoward medical occurrence in a clinic investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 30 days post dose.
| Arm | Type | Description |
|---|---|---|
| NCO-48 Fumarate | EXPERIMENTAL | NCO-48 Fumarate |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator |
| Name | Type | Description |
|---|---|---|
| NCO-48 Fumarate | DRUG | NCO-48 Fumarate |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Healthy male or female subjects 21 to 65 years of age, inclusive. 2. Female subjects of non-childbearing potential must be surgically sterile or postmenopausal, defined as spontaneous amenorrhea for at least 2 years with follicle-stimulating hormone (FSH) in the post-menopaus...