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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 7, 2022

Primary Completion Date

October 25, 2022

Study Completion Date

October 25, 2022

Conditions
Refractory Chronic Cough
Interventions
DRUG

3 mg NOC-100 (via nebulizer)

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

DRUG

1 mg NOC-110 (via DPI) [1x 1 mg capsule]

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

DRUG

3 mg NOC-110 (via DPI)

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

DRUG

Placebo (via DPI)

Participants will be randomized to receive single doses of placebo via capsule in a crossover fashion according to a prespecified randomization schedule

DRUG

6 mg NOC-110 (via DPI)

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

DRUG

Placebo (via DPI) [2x Placebo capsules]

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

Trial Locations (3)

32789

Clinical Site Partners, Leesburg

34748

Clinical Site Partners, Winter Park

85283

Celerion, Phoenix

Sponsors
All Listed Sponsors
lead

Nocion Therapeutics

INDUSTRY

NCT05628740 - 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 | Biotech Hunter | Biotech Hunter