Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT05628740•Nocion Therapeutics

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants must meet all of the following criteria to be eligible for participation in the study:
•1. Male or female participants between the ages of 18 to 65 years, inclusive, at the time of screening (Part 1) and between the ages of 18 to 85 years, inclusive, at the time of screening (Part 2).
•2. Has had rCC diagnosis for ≥ 12 months (Part 2) prior to screening.
•3. Awake-cough frequency of ≥20 per hour (average) at Screening (Part 2).
•4. Score of ≥40 mm on the Cough Severity Visual Analog Scale (VAS) at Screening (Part 2).
•5. Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the rCC. (Part 2)
•6. Body mass index (BMI) ≥19.0 and ≤32.0 kg/m2, inclusive, at Screening.
•7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2 x upper limit of normal (ULN); alkaline phosphatase (ALP) and bilirubin ≤1.5 x ULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
•8. Creatinine clearance ≥50 mL/min.
•9. Must be fully SARS-CoV-2 vaccinated.
+2 more criteria

Exclusion Criteria

•Participants who meet any one of the following criteria will be deemed ineligible for participation in the study:
•1. Is found to have positive test for SARS-CoV-2 at Screening or Check-in Day -1, whether or not this was accompanied by the clinical symptoms of COVID-19.
•2. Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with \>20 pack-year smoking history (Part 2)
•3. Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, or asthma (Part 2).
•4. History or presence of alcohol or drug use disorder, per Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), within the past 2 years prior to screening.
•5. Current opiate/opioid use in the past 7 days prior to screening, or medical history of opiate/opioid use disorder.
•6. Unable to refrain from the use of:
•1. Gabapentin, pregabalin, and/or amitryptline or other tricyclics within 4 weeks prior to screening and throughout the study (Part 2)
•2. Chronic, systemic corticosteroid use within 4 weeks prior to screening and throughout the study (Part 2).
•3. Inhalers including long-acting and short acting beta 2-agonists (LABA and SABA), and inhaled corticosteroids (ICS) within 8 weeks prior to screening and throughout the study.
+13 more criteria

Locations (3)

Celerion

Phoenix, Arizona, United States

Clinical Site Partners

Leesburg, Florida, United States

Clinical Site Partners

Winter Park, Florida, United States

Key Dates

Start Date

February 7, 2022

Primary Completion Date

October 25, 2022

Completion Date

October 25, 2022

Last Updated

March 30, 2023

Enrollment

ACTUAL participants

Conditions

Refractory Chronic Cough

Interventions

3 mg NOC-100 (via nebulizer)

DRUG

1 mg NOC-110 (via DPI) [1x 1 mg capsule]

DRUG

3 mg NOC-110 (via DPI)

DRUG

Placebo (via DPI)

DRUG

6 mg NOC-110 (via DPI)

DRUG

Placebo (via DPI) [2x Placebo capsules]

DRUG

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

NCT05599191

CoughRefractory Chronic Cough

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions