A study of safety and efficacy of JBT-101 in cystic fibrosis

Phase 1

• Conditions: Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function.; MedDRA version: 18.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002581-23-BE
• Lead Sponsor: Corbus Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-12
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Documented diagnosis of cystic fibrosis
2. =18 and < 65 years of age at the time the Informed Consent Form is signed
3. FEV1 = 40% predicted, either pre- or post bronchodilator.
4. Stable treatment of cystic fibrosis for 14 days before Visit 1.

Are the trial subjects under 18? no
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe or unstable cystic fibrosis.
2. Any of the following values for laboratory tests at Screening
a. A positive pregnancy test (also Visit 1)
b. Hemoglobin < 10 g/dL
c. Neutrophils < 1.0 x 109/L
d. Platelets < 500 cells/µL
e. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;
f. Serum transaminases > 2.5 x upper normal limit
g. Total bilirubin = 1.5 x upper limit of normal
3. Any other condition that, in the opinion of the site investigator, are clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

Study & Design

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