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NCT01497704 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation and Safety Trial of YN968D1
A Phase 1 study, sponsored by Elevar Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01497704: Completed Phase 1 study, sponsored by Elevar Therapeutics.
NCT01497704 is a Phase 1 study that has completed, run by Elevar Therapeutics. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497704, a Phase 1 study, has completed, sponsored by Elevar Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.
Primary Outcome
The primary endpoint is evaluation of safety during the first 28-day cycle of therapy following the initiation of multiple dosing of YN968D1. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology (including RBC morphology and reticulocyte count), and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collec
Interventions
- DRUG YN968D1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01497704 record still lists
NCT01497704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which YN968D1 is the first listed.
NCT01497704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497704 about?
NCT01497704 is a clinical study titled "Dose-Escalation and Safety Trial of YN968D1". This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN...
What is the current status of trial NCT01497704?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2012-04. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01497704?
The interventions under investigation include: YN968D1 (DRUG).
Who is sponsoring clinical trial NCT01497704?
This trial is sponsored by Elevar Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01497704's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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