CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 8 enrolled
Drug / intervention
Sustained Release Injectable Tacrolimusdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03626714
NCT03626714Early Ph 1Completed
CompareCT.gov

An Open-Label, First-in-human, Safety and Pharmacokinetic Study of 1-Month Sustained-Release Injectable Tacrolimus in Healthy Subjects

Auritec Pharmaceuticals·interventional·Posted Aug 13, 2018·Updated Aug 13, 2019

In Brief

A Early Phase 1 clinical trial evaluating Sustained Release Injectable Tacrolimus for Organ Transplant Rejection and Psoriasis. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrgan Transplant Rejection, Psoriasis
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedAug 13, 2018
Enrollment StartOct 16, 2018
Primary CompletionJan 5, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.9 years ago

Interventions

Sustained Release Injectable Tacrolimusdrug

Long-acting formulation of tacrolimus developed using Auritec's proprietary Plexis drug delivery technology.