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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aldeyra Therapeutics, Inc.

Criteria

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.