drugset / Trial / NCT03626714
Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
Phase 0
Completed
8 enrolled
Auritec Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-10-16
- Primary completion
- 2019-01-05
- Completion
- 2019-01-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Subcutaneous |