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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 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.

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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.

Interventions

  • DRUG Sustained Release Injectable Tacrolimus

Study Locations (1)

Texas

  • Worldwide Clinical Trials - San Antonio

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2018-10-16
Est. Completion 2019-01-05
Phase Early Phase 1

Sponsor

Auritec Pharmaceuticals

2 total trials

What the Registry Record Tells You About NCT03626714

The ClinicalTrials.gov registry entry for NCT03626714 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (98% lower). The listed sponsor is Auritec Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.