Single-dose AQ001S PK Study in Healthy Volunteers

NCT ID: NCT05148312

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-12
• Study Completion Date: 2022-02-21

Brief Summary

This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.

Detailed Description

This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml.

Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization.

The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution.

The primary safety objective is to assess the safety of AQ001S inhalation solution.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AQ001S 0.125 mg/2mL single-dose

AQ001S 0.125 mg/2 ml (budesonide 0.125 mg/2 ml inhalation solution) single-dose administered by nebulization.

Group Type: EXPERIMENTAL

Budesonide Inhalant Product

Intervention Type: DRUG

Single-dose of budesonide solution administered by nebulization.

AQ001S 0.250 mg/2mL single-dose

AQ001S 0.250 mg/2 ml (budesonide 0.250 mg/2 ml inhalation solution) single-dose administered by nebulization.

Group Type: EXPERIMENTAL

Budesonide Inhalant Product

Intervention Type: DRUG

Single-dose of budesonide solution administered by nebulization.

AQ001S 0.500 mg/2mL single-dose

AQ001S 0.500 mg/2 ml (budesonide 0.500 mg/2 ml inhalation solution) single-dose administered by nebulization.

Group Type: EXPERIMENTAL

Budesonide Inhalant Product

Intervention Type: DRUG

Single-dose of budesonide solution administered by nebulization.

Budesonide inhalation suspension 1.0 mg/2 ml single-dose

Pulmicort Respules® 1.0 mg/2 ml is a budesonide inhalation suspension administered by nebulization.

Group Type: ACTIVE_COMPARATOR

Budesonide Inhalant Product

Intervention Type: DRUG

Single-dose of budesonide solution administered by nebulization.

Interventions

Budesonide Inhalant Product

Single-dose of budesonide solution administered by nebulization.

Intervention Type: DRUG

Other Intervention Names

Budesonide solution administered by nebulization

Eligibility Criteria

Inclusion Criteria

1. Subjects who have given written informed consent.

2. Healthy volunteers of both genders, aged ≥ 18 and ≤ 60 years.

3. Subjects with body weight > 45 kg and Body Mass Index ≥ 18.5 and ≤ 24.9kg/m2.

4. Healthy volunteers are declared healthy based on medical history, physical examination, electrocardiogram, pulmonary function test (Forced Expiratory Volume in 1 second ≥ 80% of the predicted normal value and Forced Expiratory Volume in 1 second/ Forced Vital Capacity ≥ 70%).

5. Clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.

6. Subjects who never smoked.

7. Women of childbearing potential (WOCBP) may be enrolled if they practice a method of birth control with a reliability of at least 90% and agree to continue doing so throughout the treatment period (e.g. condom, intrauterine device or hormonal contraception).

8. Any female subject with childbearing potential has a negative pregnancy test at Screening visit and prior to dosing at each treatment period.

9. Reliable subjects who are willing to be available for the duration of the clinical study and willing to comply with clinical study procedures.

10. Subjects who have the ability to understand the requirements of the clinical study.

Exclusion Criteria

1. Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history) or clinically relevant laboratory abnormalities.

2. Clinically significant history or presence of pulmonary malformations, chronic bronchitis, asthma, emphysema, cystic fibrosis or any other pulmonary disease

3. History or presence of pulmonary tuberculosis.

4. Viral or bacterial upper or lower respiratory tract infection, or sinus or middle ear infection, within 4 weeks prior to the screening visit.

5. Untreated oral candidiasis.

6. History or presence of prolonged QTc interval (> 450 ms), or any other clinically significant electrocardiogram abnormalities as judged by the Investigator based on 12-lead electrocardiogram recordings at Screening Visit.

7. History or presence of malignancy of any system organ class (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years prior to Screening Visit, regardless of whether there is no evidence of local recurrence or metastases.

8. Eye disorders, especially glaucoma, or a family history of glaucoma.

9. History of alcohol or drug abuse.

10. Inability to abstain from alcohol consumption for the duration of study period.

11. Immunosuppressive treatment, including topical and systemic corticosteroids (e.g., oral, parenteral, ocular, nasal or inhaled), within 4 weeks before Screening Visit.

12. Use of prescription or non-prescription drugs, except for simple analgesics (e.g. paracetamol) and hormonal contraception for women, including vitamins, herbal and dietary supplements (including St John's Wort [Hypericum]) within 7 days (or 2 weeks if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the Screening Visit.

13. Pregnant or breastfeeding female subjects.

14. History of hypersensitivity or existing contraindication to budesonide or any other study medication ingredients.

15. Blood or plasma donation within 4 weeks prior to Screening Visit.

16. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the clinical study.

17. History or presence of any other clinically relevant disease of any major system organ class (e.g. cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological including any type of Diabetes mellitus, neurological, psychiatric or orthopedic disease) as judged by the Investigator.

18. COVID-19, Hepatitis B and C and HIV positive tests

19. Any COVID-19 vaccine within 2 weeks prior to the first dose of study drugs, and during the entire study participation including 2 weeks after the last dose of study drug.

20. Subjects who participated in an investigational study within the 12 weeks prior to the start of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aquilon Pharmaceuticals S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dobrin Svinarov, MD

Role: PRINCIPAL_INVESTIGATOR

MC Comac Medical Ltd.

Locations

MC Comac Medical Ltd.

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

BORA Study

Identifier Type: -

Identifier Source: org_study_id