RecruitingPhase 2NCT06504446
Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Taplucainium Inhalation Powder (NOC-110) in Adults With Refractory or Unexplained Chronic Cough
Sponsor
Nocion Therapeutics
Enrollment
455 participants
Start Date
Sep 24, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria15
- 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 60 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 of screening, 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).
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Interventions
DRUGNOC-110
Inhalation powder
OTHERPlacebo
Inhalation powder
Locations(107)
View Full Details on ClinicalTrials.gov
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NCT06504446