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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG TAT4 Gel concentration A
  • DRUG TAT4 Gel concentration B

Study Locations (1)

California

  • Topokine Clinical Site - Cypress

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2014-10
Est. Completion 2014-12
Phase Phase 1

Sponsor

Topokine Therapeutics

3 total trials

What the Registry Record Tells You About NCT02647853

The ClinicalTrials.gov registry entry for NCT02647853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 11 other Lipodystrophy trials with a reported enrollment target (88% lower). The listed sponsor is Topokine Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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