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

Refractory Chronic Cough Clinical Trial

Official title: A Phase 1, Two Part, Placebo-controlled, Single Dose Study in Healthy Volunteers and Multiple Dose Study in Patients With Refractory Chronic Cough to Assess the Safety, Tolerability, and PK of NTX-1175 Administered Via Nebulizer (NOC-100) and Dry Powder Inhaler (NOC-110)

Status Completed

Clinical Trial 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).

Clinical Trial Description

Part 1 is a randomized, double-blinded 3 period crossover and 1 period parallel study of single dose administration of NOC-110 via dry powder inhaler, preceded by a reference period of NOC-100 administered via nebulizer. A total of 12 healthy participants will be enrolled to ensure that 9 participants complete this part of study.

Part 2 is a randomized, double-blinded, placebo-controlled, multiple-dose, parallel design study in patients with refractory chronic cough. A total of 12 participants will be enrolled to ensure that 8 participants complete this part of study. ;

Related Conditions & MeSH terms

• Cough
• Refractory Chronic Cough

• NCT number: NCT05628740
• Study type: Interventional
• Source: Nocion Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: February 7, 2022
• Completion date: October 25, 2022