Trials / Completed
CompletedNCT04375436
Safety and Tolerability of NTRX-07 in Healthy Volunteers
NTRX 07-C101: A Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Single Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- NeuroTherapia, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).
Detailed description
Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach. Up to 6 cohorts, A-F, are planned for a total of 48 completing subjects. Each dose cohort will be randomized with 6 subjects receiving active drug and 2 placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NTRX-07-SDD | NTRX-07-SDD for oral administration |
Timeline
- Start date
- 2019-10-10
- Primary completion
- 2020-05-15
- Completion
- 2020-06-30
- First posted
- 2020-05-05
- Last updated
- 2023-11-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04375436. Inclusion in this directory is not an endorsement.