A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants
Condition: Healthy Volunteers
Intervention: Aclidinium Bromide 400 μg
Intervention description: Aclidinium Bromide 400 μg BID inhalation powder. One oral inhalation via Genuair® dry powder inhaler (DPI)
Intervention MeSH terms: Bromides
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single and Multiple Dose (Twice-Daily)
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      A Phase I, single centre, open-label study to investigate the pharmacokinetics (PK), safety
      and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide in
      healthy Chinese male and female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ability to communicate with medical team and staff, willing to participate in the
             trial, willing to give written informed consent, and comply with the trial
             restrictions.

          2. Healthy subjects: Chinese men or non-pregnant, non-lactating women, 18 through 45
             years old at Visit 1 (Screening).

          3. Have a body mass index (BMI) ≥19 kg/m2 and ≤ 26 kg/m2

          4. Resting heart rate ≥ 50 beats per minute (bpm) and ≤ 100 bpm at Visit 1 (Screening)
             and at admission to the unit on Day -1 at Visit 2.

          5. Non-smoker (never smoked or has not smoked within 2 years prior to the first dose of
             investigational product [IP]).

          6. Demonstrate satisfactory technique in the use of the DPI at screening.

        Exclusion Criteria:

          1. History of any significant drug allergy or hypersensitivity to aclidinium bromide or
             other muscarinic antagonists.

          2. Have abnormal and clinically significant results on the physical examination, medical
             history, serum biochemistry, haematology, or urinalysis at Visit 1 (Screening).

          3. Sustained resting systolic blood pressure ≥ 140 or ≤ 90 mmHg and resting diastolic
             blood pressure ≥ 90 or ≤ 50 mmHg at Visit 1 (Screening) or Day -1 at Visit 2.

          4. Electrocardiogram (ECG) showing corrected QT interval (QTc) using Fridericia's
             correction (QTcF) ≥ 450 msec for male participants and ≥460 msec for female
             participants as indicated in the centralised reading report assessed at Screening
             (Visit 1).

          5. Have a history of alcohol or substance abuse within the previous 5 years, as reported
             by the participants.

          6. Positive results for drugs of abuse at Visit 1 (Screening).

          7. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody and/or
             human immunodeficiency virus (HIV) antibodies at Visit 1 (Screening).

          8. Use of any medication within 2 weeks or within the equivalent time of 5 half-lives of
             taking the last dose (whichever is longer) before the first dose of IP, or hormonal
             drug products and traditional Chinese medicines within 30 days before the first dose
             of IP.

          9. Have consumed caffeine or any grapefruit-containing products within 48 hours or
             alcohol within 72 hours before Day -1.

         10. Participation in any other clinical investigation using an experimental drug requiring
             repeated blood or plasma draws within 60 days of Day 1 at Visit 2.

         11. Have participated in a blood/plasma donation or blood loss greater than 400 mL within
             90 days, or greater than 200 mL within 30 days prior to screening (Visit 1).

         12. Recent history of a disease or condition that would result in any residual upper
             respiratory airways/lung inflammatory process or residual limited lung function at the
             time of Day 1 at Visit 2.

         13. History of confirmed COVID-19 infection.

         14. Have any gastrointestinal, hepatic, or renal condition that might affect the
             absorption, distribution, biotransformation, or excretion of aclidinium bromide.

         15. Inability to be venipunctured or tolerate venous access as determined by the PI or
             designee.

         16. Participants unable to give their consent, or participants of consenting age but under
             guardianship, or vulnerable participants.

         17. In the opinion of the PI, participants who are unlikely to comply with the protocol
             requirements, instructions, and trial-related restrictions.

         18. Participant is a relative of the Investigator or any sub-investigator, research
             assistant, pharmacist, trial coordinator, or other staff or directly involved in the
             conduct of the clinical trial.

         19. Any other conditions that, in the Investigator's opinion, might have indicated the
             participant to be unsuitable for the study (e.g. confirmed/suspected COVID-19)