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NCT01636141 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects
A Phase 1 study, sponsored by Olatec Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01636141: Completed Phase 1 study, sponsored by Olatec Therapeutics.
NCT01636141 is a Phase 1 study that has completed, run by Olatec Therapeutics. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01636141, a Phase 1 study, has completed, sponsored by Olatec Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.
Primary Outcome
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event. Local skin irritation will be assessed at each visit based on individual signs and symptoms of skin tolerability for erythema, pruritus, scaling/dryness, edema and stinging/burning.
Interventions
- DRUG Placebo gel
- DRUG OLT1177 Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01636141 record still lists
NCT01636141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo gel is the first listed.
NCT01636141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636141 about?
NCT01636141 is a clinical study titled "Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects". The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.
What is the current status of trial NCT01636141?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01636141?
The interventions under investigation include: Placebo gel (DRUG), OLT1177 Gel (DRUG).
Who is sponsoring clinical trial NCT01636141?
This trial is sponsored by Olatec Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01636141's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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