NCT05501574

An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: TFF Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Part A: This is an open label, single-arm study that will evaluate the safety, tolerability, efficacy and PK of Tacrolimus Inhalation Powder over 12 weeks in lung transplant patients who require reduced blood levels of tacrolimus due to kidney toxicity. Tacrolimus Inhalation Powder is being developed as an alternative to oral tacrolimus for prevention of rejection in adult lung transplant recipients. Part B of this study is an optional safety extension following successful completion of Part A. Patients would have the option to continue Tacrolimus Inhalation Powder for up to 1 year, with a possibility to extend to 2 years pending analysis of Part A data. Participants would return to clinic every 12 weeks for safety assessments, dose adjustments, and to receive more Tacrolimus Inhalation Powder. After 2 years, if the drug is still under development, the subject will be invited to continue receiving Tacrolimus Inhalation Powder under a special access program.

Conditions

• Lung Transplant Rejection

Interventions

Type	Name	Description
DRUG	Tacrolimus Inhalation Powder	Tacrolimus powder for inhalation to prevent acute allograft rejection
DEVICE	Plastiape RS00 Dry Powder inhaler device	dry powder inhaler device

Timeline

• Start date: 2023-04-18
• Primary completion: 2024-10-29
• Completion: 2024-12-23
• First posted: 2022-08-15
• Last updated: 2025-01-06

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated device study