BA/BE Study of Immediate Release JBT-101 Oral Tablet (QCL117941)
Research type
Research Study
Full title
A Phase I Study to Evaluate the Safety and Pharmacokinetics of Lenabasum Following a Single Oral Dose in Japanese and Non-Japanese Healthy Volunteers.
IRAS ID
222737
Contact name
Scott Constantine
Contact email
Sponsor organisation
Corbus Pharmaceuticals, Inc.
Eudract number
2017-000210-38
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
The Sponsor, Corbus Pharmaceuticals, Inc. is developing the test medicine, Lenabasum (JBT-101), for the potential treatment of diseases with excessive inflammation and scarring, such as cystic fibrosis and systemic sclerosis. Researchers anticipate that Lenabasum will have an anti-inflammatory and anti-scarring effect.\nThis is a single centre, single dose study in healthy male and female volunteers aged 18 to 55. The study will enrol Japanese and non-Japanese healthy volunteers, to compare results in both Japanese and non-Japanese populations. Approximately 26 Japanese and 9 non-Japanese subjects will be enrolled, with a maximum of six replacement subjects to be added if necessary. \nThe study aims to identify the movement of the test medicine within the body and the proportion that moves into the blood. Safety will be measured throughout. Blood and urine samples will be taken throughout to identify the amount of test medicine and breakdown products (metabolites) in both. \nThe study will consist of one visit where volunteers will receive a single dose of the test medicine, administered following an overnight fast. This will be given in an oral, powder-in-capsule formulation (recipe). There will be four cohorts of volunteers, cohorts 1 to 3 will be randomised and include the Japanese volunteers only, where 10 mg is to be dosed in cohort 1, 20 mg in cohort 2 and 40 mg in cohort 3. Cohort 4 will include non-Japanese subjects only, who will receive 20 mg of the test medicine. \nVolunteers will be discharged 32-hours post dose and will receive a follow up call 3-7 days post dose to ensure their continued safety and wellbeing. \n
REC name
Wales REC 1
REC reference
17/WA/0081
Date of REC Opinion
12 May 2017
REC opinion
Further Information Favourable Opinion