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NCT03626714 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
A Early Phase 1 study of Psoriasis and Organ Transplant Rejection, sponsored by Auritec Pharmaceuticals.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03626714: Completed Early Phase 1 study of Psoriasis and Organ Transplant Rejection, sponsored by Auritec Pharmaceuticals.
NCT03626714 is a Early Phase 1 study of Psoriasis and Organ Transplant Rejection that has completed, run by Auritec Pharmaceuticals. The registered enrollment target is 8 participants, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03626714, a Early Phase 1 study of Psoriasis and Organ Transplant Rejection, has completed, sponsored by Auritec Pharmaceuticals.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This first-in-human study is designed to assess the safety and pharmacokinetic (PK) profile of sustained-release (SR) depot tacrolimus, which will be administered as a single dose of 0.1 mg/kg by subcutaneous (SC) injection in healthy subjects.
Primary Outcome
Adverse events were documented at each study visit according to the criteria set forth in the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as follows: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening).
Conditions Studied
Interventions
- DRUG Sustained Release Injectable Tacrolimus
Study Locations (1)
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2019-01-05 |
| Phase | Early Phase 1 |
What the finished NCT03626714 record still lists
NCT03626714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Psoriasis appearing as the primary indexed condition, and to 1 intervention - of which Sustained Release Injectable Tacrolimus is the first listed.
NCT03626714 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03626714 about?
NCT03626714 is a clinical study titled "Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study". This first-in-human study is designed to assess the safety and pharmacokinetic (PK) profile of sustained-release (SR) depot tacrolimus, which will be administered as a single dose of 0.1 mg/kg by subcutaneous (SC) injection in healthy subjects.
What is the current status of trial NCT03626714?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2018-10-16. Estimated completion is 2019-01-05.
What conditions does trial NCT03626714 study?
This clinical trial studies the following conditions: Psoriasis, Organ Transplant Rejection.
What interventions are being tested in trial NCT03626714?
The interventions under investigation include: Sustained Release Injectable Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT03626714?
This trial is sponsored by Auritec Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03626714 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03626714's enrollment target sits among peer trials
8 123rd of 125 higher than 3 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis 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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