A Phase 1, Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects

Nuance Pharma (shanghai) Co., Ltd1 site in 1 country28 target enrollmentMarch 6, 2023

ConditionsChronic Obstructive Pulmonary Disease

InterventionsEnsifentrine

DrugsEnsifentrine

Overview

Phase: Phase 1
Intervention: Ensifentrine
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Nuance Pharma (shanghai) Co., Ltd
Enrollment: 28
Locations: 1
Primary Endpoint: Cmax of RPL554
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1, open-label, parallel cohort study to evaluate the PK, safety and tolerability of nebulized ensifentrine following administration of single and multiple doses in healthy Chinese male subjects.

Detailed Description

This study consists of two cohorts, and approximately a total of up to 28 healthy male subjects, 14 subjects in Cohort 1, and 14 subjects in Cohort 2, will be enrolled. Cohort 2 will be randomly assigned to Sequence 1 and Sequence 2 according to the ratio of 1:1. Treatment Group 1. Cohort 1: subjects will receive a 3 mg ensifentrine single dose, followed by 3 mg repeated dose (twice daily, BID). 2. Cohort 2: subjects will receive two single doses of 1.5 mg and 6 mg ensifentrine, separated by at least a 7-day washout period using crossover design.

Registry

clinicaltrials.gov

Start Date

March 6, 2023

End Date

April 18, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Nuance Pharma (shanghai) Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects (18-50 yrs) who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECG without abnormality or with abnormality of no clinical significance;
•A male subject must agree to use contraception as detailed in the protocol from the screening visit to within 30 days of the last dose after study completion and refrain from donating sperm during this period;
•Subjects never smoke or is ex-smoker for ≥ 12 months,never chewing tobacco within 90 days prior to screening;
•Body weight must be ≥ 50 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2.

Exclusion Criteria

•History or current malignancy of any organ system, treated or untreated within the past 5 years;
•Known allergy, immune reaction, or intolerance to ensifentrine or any of the excipients of the formulation and/or ineligible to receive ensifentrine;
•Subjects with the history of pulmonary and cardiovascular disease;
•Any chronic condition or disease, including but not limited to: Metabolism, endocrine (such as diabetes, hypothyroidism/hyperthyroidism), liver, kidney, gastrointestinal tract, hematology or nervous system and other diseases;
•Respiratory tract infection (upper and/or lower) treated with antibiotics within 12 weeks of screening visit;
•Current infection of clinical significance or known ongoing inflammatory condition;
•Live or attenuated vaccine(s) within 1 month prior to screening, or plan to receive such vaccines during the study;
•Immunotherapy within 30 days of screening;
•Subjects who participated in any other interventional clinical trials within 3 months prior to screening;
•Subjects who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days prior to screening or have used any drugs within 14 days prior to screening;