Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults with Refractory or Unexplained Chronic Cough

Launched by NOCION THERAPEUTICS · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NOC-110 for adults who suffer from a persistent cough that lasts for more than a year and doesn't have a clear cause. The goal is to see if this inhaled medication is effective, safe, and well-tolerated when taken once a day. The trial is currently looking for participants between the ages of 18 and 75 who meet specific criteria, such as having this chronic cough for at least 12 months and being able to provide informed consent.

Participants will be randomly assigned to receive either the medication or a placebo (a treatment that looks the same but has no active ingredients) and will be monitored closely throughout the study. It’s important to note that people with certain health conditions, recent infections, or those who smoke or have specific allergies may not be eligible to participate. This trial aims to provide valuable information about how well NOC-110 works for those struggling with this challenging condition.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Refractory or unexplained chronic cough for ≥ 12 months.
• • Women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study.
• • Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol.
• • Able to provide Informed Consent.
• Exclusion Criteria:
• • Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
• • Participants who are currently participating in another drug or device clinical study
• • Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
• • Current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma, or other pulmonary disease.
• • Respiratory tract infection within 4 weeks of Screening or during screening period.
• • Any female who is pregnant or lactating or wishing to become pregnant.
• • Donation of \> 1 Unit (450 milliliter or more) of blood within 90 days prior to the first dosing.
• • Alcohol or drug use disorder within the past 2 years.
• • Current smoker/vaper or individuals who have given up smoking within the past 6 months, and/or those with \>20 pack-year smoking history.
• • Current opiate/opioid use or medical history of opiate/opioid use disorder. History of concurrent malignancy or recurrence of malignancy in the last 2 years.
• • Body Mass Index of ≥40 kg/m2.
• • Positive results for human immunodeficiency virus, hepatitis B, or hepatitis C virus.
• • Unable to refrain from the use of medications and treatments that can impact cough during the study.
• • Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).