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NCT02647853 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
A Phase 1 study of Lipodystrophy and Nasolabial Folds, sponsored by Topokine Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02647853: Completed Phase 1 study of Lipodystrophy and Nasolabial Folds, sponsored by Topokine Therapeutics.
NCT02647853 is a Phase 1 study of Lipodystrophy and Nasolabial Folds that has completed, run by Topokine Therapeutics. The registered enrollment target is 16 participants, below the 132-participant average among 11 other Lipodystrophy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02647853, a Phase 1 study of Lipodystrophy and Nasolabial Folds, has completed, sponsored by Topokine Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.
Primary Outcome
Adverse event rates by System Organ Class, as graded by current CTCAE
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAT4 Gel concentration A
- DRUG TAT4 Gel concentration B
Study Locations (1)
California
- Topokine Clinical Site - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02647853 record still lists
NCT02647853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 132-participant average among 11 other Lipodystrophy trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Lipodystrophy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02647853 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02647853 about?
NCT02647853 is a clinical study titled "Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers". This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.
What is the current status of trial NCT02647853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-10. Estimated completion is 2014-12.
What conditions does trial NCT02647853 study?
This clinical trial studies the following conditions: Lipodystrophy, Nasolabial Folds, Lipoatrophy.
What interventions are being tested in trial NCT02647853?
The interventions under investigation include: Placebo (DRUG), TAT4 Gel concentration A (DRUG), TAT4 Gel concentration B (DRUG).
Who is sponsoring clinical trial NCT02647853?
This trial is sponsored by Topokine Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02647853 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02647853's enrollment target sits among peer trials
16 10th of 11 higher than 2 of 11 other Lipodystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lipodystrophy 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.
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