Last reviewed · How we verify
A Phase 1, Randomized, Double-Blind, Single Ascending Dose Trial of the Safety, Tolerability and Pharmacokinetics of NPT200-11 in Healthy Subjects
The purpose of this study is to determine the safety, tolerability and blood levels of orally administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be determined.
Details
| Lead sponsor | Neuropore Therapies Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 55 |
| Start date | 2015-07 |
| Completion | 2016-02 |
Conditions
- Healthy Volunteers
Interventions
- NPT200-11
- Placebo
Primary outcomes
- Safety, including adverse events, physical examinations, ECGs, clinical laboratory tests — Screening (28 days prior to dosing) through Day 7
Safety, as determined by the number of participants with adverse events related to treatment, the number of participants with clinically significant changes in blood pressure, heart rate and respiration, the number of participants with abnormal laboratory values, the number of participants with abnormal ECGs.
Countries
United States