Evaluating the Safety, Tolerability and Effectiveness of ADX-629 t to Treat Chronic Cough


About this study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of ADX-629 300 mg administered orally BID for 14 days to approximately 50 adult subjects with refractory or unexplained chronic cough.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Vivek Iyer, M.D., M.P.H.

Closed for enrollment

More information


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