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NCT01955564 · ClinicalTrials.gov registry record · Phase 1
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
A Phase 1 study, sponsored by Newron Pharmaceuticals SPA.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01955564: Completed Phase 1 study, sponsored by Newron Pharmaceuticals SPA.
NCT01955564 is a Phase 1 study that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955564, a Phase 1 study, has completed, sponsored by Newron Pharmaceuticals SPA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.
Primary Outcome
Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.
Interventions
- DRUG NW-3509a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT01955564 record still lists
NCT01955564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which NW-3509a is the first listed.
NCT01955564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01955564 about?
NCT01955564 is a clinical study titled "A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.". This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this st...
What is the current status of trial NCT01955564?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2013-06. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01955564?
The interventions under investigation include: NW-3509a (DRUG).
Who is sponsoring clinical trial NCT01955564?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01955564's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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