Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 will evaluate the safety, tolerability and PK of single doses of three dose levels of
      NTX-1175 drug substance administered by dry powder inhaler (NOC-110) compared to a single
      dose reference nebulizer (NOC-100) treatment in healthy participants.

      Part 2 will evaluate the safety, tolerability and PK of multiple doses of NTX-1175 drug
      substance administered by dry powder inhaler (NOC-110) to participants with refractory
      chronic cough. Part 2 will also evaluate the treatment effect of multiple doses of one dose
      level of NTX-1175 drug substance administered by dry powder inhaler (NOC-110).
    

Detailed description: 
      Part 1 is a randomized, double-blinded 3 period crossover and 1 period parallel study of
      single dose administration of NOC-110 via dry powder inhaler, preceded by a reference period
      of NOC-100 administered via nebulizer. A total of 12 healthy participants will be enrolled to
      ensure that 9 participants complete this part of study.

      Part 2 is a randomized, double-blinded, placebo-controlled, multiple-dose, parallel design
      study in patients with refractory chronic cough. A total of 12 participants will be enrolled
      to ensure that 8 participants complete this part of study.
    

Intervention name(s): 3 mg NOC-100 (via nebulizer); 1 mg NOC-110 (via DPI) [1x 1 mg capsule]; 3 mg NOC-110 (via DPI); Placebo (via DPI); 6 mg NOC-110 (via DPI); Placebo (via DPI) [2x Placebo capsules]
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants determined to be eligible for Part 1 of the study will be enrolled and will be assigned to receive a single dose of the reference nebulizer treatment of NOC 100 at 3 mg (Treatment A) in Period 1; Participants will be randomized to receive single doses of 1 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule; Participants will be randomized to receive single doses of 3 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule; Participants will be randomized to receive single doses of placebo via capsule in a crossover fashion according to a prespecified randomization schedule; Participants will be randomized to receive single doses of 6 mg NOC-110 via DPI in a parallel fashion according to a prespecified randomization schedule; Participants will be randomized to receive single doses of Placebo (via DPI) [2x Placebo capsules] in a parallel fashion according to a prespecified randomization schedule
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: randomized, double-blind, placebo-controlled, 3-period crossover, and 1-period parallel study.
Part 2: randomized, double-blind, placebo-controlled, multiple-dose, parallel-design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment