A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough

ID#: NCT05392192

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: April 07, 2022

End Date: December 01, 2023

Contact Information:
BILL CAVANAGH
781-257-3063
Summary: A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Chronic Cough
Eligibility:

Inclusion Criteria:

- Adults ≥18 to ≤80 years of age

- History of refractory or unexplained chronic cough

- Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough

- Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable

- Agree to discontinue antitussive medications for the trial duration

Exclusion Criteria:

- Current smoker (including cannabis products) or previous smoker having recently given up smoking or has a history of smoking of >20 pack-years

- History of significant cardiovascular disease or any clinically significant abnormalities in rhythm or conduction

- History or presence of significant hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

- History of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.

- Recent history of drug or alcohol abuse or a positive urine drug test at screening

- Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1 and HIV-2

- Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI within 3 months of Screening.