A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

March 6, 2023

Primary Completion Date

April 18, 2023

Study Completion Date

April 18, 2023

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Ensifentrine

14 Subjects enrolled will use one 3 mg/2.5 mL ampule for the 3 mg dose, subjects will receive a 3 mg ensifentrine single dose, followed by 3 mg repeated dose (twice daily, BID). On the dosing day (Day 1), subjects will receive a single dose of 3 mg ensifentrine. On Day 4, subjects will receive multiple doses of 3 mg ensifentrine BID for 3 days (Day 4 to Day 6), and a morning dose will be administered on Day 7.

DRUG

Ensifentrine

14 subjects will be enrolled in this cohort, then randomly assigned to one of 2 treatment sequences (6mg and 1.5mg single dose). Subjects will 2 different dose levels of study drug. Two 3 mg/2.5 mL ampules will be needed for the 6 mg dose (5 mL total volume) and the 1.5 mg dose will be achieved using an appropriate dilution protocol described in the pharmacy manual.

Trial Locations (1)

Unknown

The Third Hospital of Changsha, Changsha

All Listed Sponsors
lead

Nuance Pharma (shanghai) Co., Ltd

INDUSTRY