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Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study

NCT03626714 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-08-13

Study results available
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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.

Conditions

Interventions

DRUG

Sustained Release Injectable Tacrolimus

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Auritec Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • George J Atiee, MD · Worldwide Clinical Trials

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-01-05
Completion
2019-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03626714 on ClinicalTrials.gov