Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT06514157
Eligibility Criteria:
Inclusion Criteria:
1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. Chinese participants who are healthy
3. Body weight ≥ 45 kg for female participants and ≥ 50 kg for male participants and body BMI ≤ 26 kg/m2 at Visit 1 (screening).
4. Male and non-pregnant, non-lactating female.
5. Provision of signed and dated, written informed consent prior to any study specific procedures.
6. 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.
7. Non-smoker.
8. Must be able to demonstrate proper inhalation technique using the Vitalograph AIM device 3 repeated times as well as be able to use the BDA MDI according to instructions at Visit 1 (screening) and Day -1.
Exclusion Criteria:
1. As judged by the investigator, any evidence which in the investigator's opinion makes it undesirable for the participant to participate in the study.
2. History of any significant drug allergy or hypersensitivity to albuterol sulfate or other beta-adrenergic agonists or to budesonide or other corticosteroids.
3. 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.
4. Have any gastrointestinal, hepatic, or renal condition that might affect the absorption, distribution, biotransformation, or excretion of drugs.
5. 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 study intervention, or hormonal drug products and traditional Chinese medicines within 30 days before the study intervention.
6. Participation in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days or 5 half-lives of the drugs (whichever takes longer) of Day 1 at Visit 2.
7. Have abnormal and clinically significant results on the physical examination, medical history, clinical chemistry, haematology, or urinalysis at Visit 1 (screening) or Day -1 at Visit 2.
8. 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.
9. 12-lead ECG showing QTcF ≥ 450 msec for participants as indicated in the reading report assessed at Visit 1 (screening).
10. Positive test results for syphilis antibody, HBsAg, hepatitis C antibody and/or HIV I antibodies at Visit 1 (screening).
11. Have a history of alcohol or substance abuse within the previous 5 years as reported by the participant.
12. Positive results for drugs of abuse at Visit 1 (screening) or Day -1 at Visit 2.
13. 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).
14. Inability to be venipunctured or tolerate venous access as determined by the PI or designee.
15. Participants unable to give their consent, or participants of consenting age but under guardianship, or vulnerable participants.
16. In the opinion of the PI, participants who are unlikely to comply with the protocol requirements, instructions, and study-related restrictions.
17. Participants who are relatives of the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or directly involved in the conduct of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06514157
Study Brief:
Protocol Section:
NCT06514157