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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03298672 | Safety, Tolerability, and Pharmacokinetics Study of NDX-1017 | PHASE1 | COMPLETED | 88 | — | — | Oct 9, 2017 | Sep 5, 2019 | Sep 10, 2019 | 1 | United States |
Safety and tolerability of single or multiple ascending doses of NDX-1017 as measured by vital signs and clinical laboratory measurements.
| Arm | Type | Description |
|---|---|---|
| NDX-1017 | EXPERIMENTAL | NDX-1017 will be administered via subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered via subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| NDX-1017 | DRUG | Solution of NDX-1017 for subcutaneous injection |
| Placebo | DRUG | Placebo solution for subcutaneous injection |
INCLUSION CRITERIA: * Generally in good health * Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at Screening, with minimum weight of 60 kg. (No BMI upper limit for mild AD and amnestic MCI subjects) * Male subjects and their partners must be willing to comply with the contraceptive requirements o...