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

Purpose

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.

Condition

  • Refractory or Unexplained Chronic Cough

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NOC-110 1mg 		NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler.
  • Drug: NOC-110
    Inhalation powder
    Other names:
    • taplucainium
Experimental
NOC-110 3mg 		NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler.
  • Drug: NOC-110
    Inhalation powder
    Other names:
    • taplucainium
Experimental
NOC-110 6mg 		NOC-110 (taplucainium) administered by daily dry powder inhalation. NOC-110 contains a dry powder lactose blend containing drug substance taplucainium administered using an available inhaler.
  • Drug: NOC-110
    Inhalation powder
    Other names:
    • taplucainium
Placebo Comparator
Placebo 		The matching placebo contains inhalation grade lactose blended with arginine. The blend is taste masked to the active drug product to minimize unblinding due to taste differences. The matching placebo will be administered via the same inhaler.
  • Other: Placebo
    Inhalation powder

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Mario Castro
913-588-7529
mcastro2@kumc.edu

More Details

Status
Recruiting
Sponsor
Nocion Therapeutics

Study Contact

Nocion Clinical Trials
781-761-2050
clinicaltrials@nociontx.com

Detailed Description

Approximately 455 participants will take part in the study. It is anticipated that up to 1264 participants will be screened. Participation will be approximately 13 weeks.