Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough

Launched by KHOLOOD ALTASSAN · May 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SC0023, which is an oral spray designed to help adults suffering from chronic cough that hasn’t improved despite other treatments. The trial will last for 14 days and involves about 20 participants who will receive either the SC0023 spray or a placebo (a treatment with no active ingredients) without knowing which one they are getting. This is done to ensure the results are reliable.

To be eligible for this study, participants must be between 18 and 80 years old and have a chronic cough that has lasted for at least six months, with an average of at least four coughs per hour while awake. They also need to score a certain level of cough severity during screening. However, people who are current smokers, have certain lung diseases, or have a history of specific health issues are not eligible. Those who join the study can expect to be monitored closely and will need to follow specific guidelines regarding medications and lifestyle during the trial. This study aims to determine if SC0023 is a safe and effective option for managing chronic cough in adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females between 18-80 years
• • Capable of giving signed informed consent
• • Diagnosed with RCC (including unexplained chronic cough) for at least 6 months and at least 4 coughs per hour on average during awake hours at Screening.
• • Score ≥ 40 mm on cough severity VAS at screening.
• • Normal FEV/FVC
• • Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose.
• Exclusion Criteria:
• • Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history.
• • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma.
• • Respiratory tract infection within 4 weeks before screening.
• • History of malignancy in the last 5 years.
• • History of alcohol or drug abuse within the last 3 years.
• • Opioid use in last 7 days of screening.
• • History of a positive serologic test for, hepatitis B virus surface antigen, or hepatitis C virus.
• • Previous participation in clinical trial in last 30 days or 6-half lives of test drug activity.
• • Use of prohibited medications anti-tussive therapy, gabapentin, pregabalin, baclofen, tricyclics, systemic corticosteroids, ACE inhibitors, beta blockers.
• • Use of dietary supplements containing magnesium for the duration of the study.
• • History of myocardial infarction or other cardiac disorders.
• • History of any clinically significant or psychiatric condition that in the eyes of the Investigator or designee would not be suitable for this study. Or if in the eyes of the Investigator or designee may prove noncompliant to study procedures.
• • Spouses or other family members with a chronic cough in household or
• • Living and working in an excessively loud workplace (e.g. building site)