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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NTX-1175 | Unknown | 1 mg | Other |
| Comparator | NTX-1175 | Unknown | 3 mg | Other |
| Comparator | NTX-1175 | Unknown | 6 mg | Other |