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

Phase 1

• Conditions: Cystic fibrosis; MedDRA version: 20.0Level: 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-IT
• Lead Sponsor: CORBUS PHARMACEUTICALS, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-04-10
• Study Start: 2021-01-20
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Documented diagnosis of cystic fibrosis
+
1. =18 and < 65 years of age at the time the Informed Consent Form is signed
2. FEV1 = 40% predicted, either pre- or post bronchodilator.
3. 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

Study & Design

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