A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study

Phase 1

Active, not recruiting

• Conditions: Cystic Fibrosis; MedDRA version: 7.1Level: LLTClassification code 10011762

• Registration Number: EUCTR2005-000313-35-GB
• Lead Sponsor: Aerovance Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-17
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Male or female subjects 12 years of age or older
2. Subjects with mild to moderate CF defined as, FEV1 predicted between 47% and 84% with no exacerbation for 4 weeks
3. Subjects and/or parents or guardians who are able and willing to give written informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who do not conform to the above inclusion criteria.
2. Subjects who have been on CF medication for less than 4 weeks (Part A) or less than 2 weeks (Part B).
3. Female subjects who are pregnant or breast-feeding, or of childbearing potential who are not using acceptable methods for contraception (reliable contraceptive measures include the following: systemic contraceptive [oral, implant, injections], diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide).
4. Subjects who have undergone lung transplant surgery.
5. Subjects who do not meet the following concomitant medication criteria:
Part A: Subjects who have had changes in their CF medication (dose or medication type) in the 4 weeks prior to enrollment.
Part B: Subjects who have had changes in their CF medication (dose or medication type) in the 2 weeks prior to Day 1 of subject dosing.
6. Subjects with any other clinically significant lung disease as determined by the investigator.
7. Any clinically significant disease or condition that may interfere with the compound or outcome of the study (e.g., metabolic conditions, renal, cardiac, or hepatic conditions) as determined by the investigator.
8. Subjects who cannot communicate reliably with the investigator.
9. Subjects who are unlikely to cooperate with the requirements of the study.
10. Subjects who have participated in an investigational study within 30 days prior to Day 1 of dosing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified