drugset / Trial / NCT05628740

Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175

NCT05628740 ↗

Phase 1 Completed 24 enrolled Nocion Therapeutics
RandomizedSequentialDouble-blindTreatment

Summary

Part 1 will evaluate the safety, tolerability and PK of single doses of three dose levels of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) compared to a single dose reference nebulizer (NOC-100) treatment in healthy participants. Part 2 will evaluate the safety, tolerability and PK of multiple doses of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) to participants with refractory chronic cough. Part 2 will also evaluate the treatment effect of multiple doses of one dose level of NTX-1175 drug substance administered by dry powder inhaler (NOC-110).

Timeline

Start
2022-02-07
Primary completion
2022-10-25
Completion
2022-10-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator NTX-1175 Unknown 1 mg Other
Comparator NTX-1175 Unknown 3 mg Other
Comparator NTX-1175 Unknown 6 mg Other