Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita
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|ClinicalTrials.gov Identifier: NCT00716014|
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : November 19, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pachyonychia Congenita||Drug: TD101 Drug: Normal saline (placebo)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Single-Center, Placebo-Controlled, Rising Dose to Tolerance and Safety Study of TD101, an siRNA Designed for Treatment of Pachyonychia Congenita|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Active Comparator: Foot 1
An active drug injection of TD101 is injected into a callus on the bottom of one foot.
TD101 is injection into a callus on the bottom of one of the patient's feet
Placebo Comparator: Foot 2
An injection of placebo (normal saline) is injected into a callus on the bottom of one foot.
Drug: Normal saline (placebo)
A normal saline solution (placebo) is injected into one of the patient's feet.
- Determine safety/toxicity of TD101 [ Time Frame: 18 weeks, followed by 3-month wash out period ]
- Determine efficacy of TD101 [ Time Frame: 18 weeks, followed by 3-month wash out period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716014
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Sancy A Leachman, MD, PhD||PC Project|