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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 is a Phase 1 study that has completed, run by Elevar Therapeutics. The registered enrollment target is 55 participants.
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.
Interventions
- DRUG YN968D1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01497704
The ClinicalTrials.gov registry entry for NCT01497704 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elevar Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which YN968D1 is the first listed.
NCT01497704 reports 0 study locations.
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.
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