Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough
About the study
This is a phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of Taplucainium Inhalation Powder (NOC-110) once daily in adults with refractory or unexplained chronic cough.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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 (not including resolved childhood asthma), or other pulmonary disease.
- Respiratory tract infection within 4 weeks of Screening.
- 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).
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Refractory or Unexplained Chronic Cough
Age
18 - 80
Phase
PHASE2
Participants Needed
325
Est. Completion Date
Nov 10, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Nocion Therapeutics
ClinicalTrials.gov NCT Identifier
NCT06504446
Study Number
NOC110-C-202
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