MBS2320 - SAD/MAD/Food Effect/Relative Bioavailability and DDI Study
Research type
Research Study
Full title
A Four-Part Phase-1 Study Investigating the Tolerability, Safety and Pharmacokinetics (PK) of MBS2320 following Ascending Single and Multiple Oral Doses in Healthy Subjects and Multiple Oral Doses in Subjects with Rheumatoid Arthritis (RA) Also Treated with Methotrexate, the Effect of Food on the PK of MBS2320 in Healthy Subjects, the Relative Bioavailability in Healthy Subjects of Encapsulated Micronized MBS2320 versus MBS2320 in Suspension in Healthy Subjects, and the PK interaction of MBS2320 and Methotrexate in Subjects with RA
IRAS ID
180668
Contact name
Jim Bush
Contact email
Sponsor organisation
Modern Biosciences Plc.
Eudract number
2015-001474-18
Duration of Study in the UK
1 years, 0 months, 5 days
Research summary
MBS2320 is an investigational medication which will be tested in humans for the first time.
This study consists of 4 parts.
Part A
64 healthy subjects to be studied in 8 groups. In each of Groups 6 subjects will receive MBS2320, and 2 subjects will receive placebo. The planned dose range is 2 – 600mg.Part B
24 healthy subjects who will be studied in 3 groups. Each subject will receive 14 daily doses (or twice daily doses if considered necessary based on Part A results) at a single dose level. Dose level will be confirmed following completion of part A.Part C
8 healthy subjects will be enrolled. Each subject will participate in 2 treatment periods. Subjects will be randomised in an equal ratio to 1 of 2 treatment sequences, receiving a single oral dose of MBS2320 as either a capsule or oral suspension in Treatment Period 1, and vice versa in Treatment Period 2.
Part C will be conducted at a dose level found to be safe and well tolerated in Part A.Part D
12 subjects with Rheumatoid Arthritis will be enrolled.
Each subject will receive 14 daily doses (or twice daily doses if considered necessary based on Part A results) of MBS2320 from Days 3 to 16. On Days 1, 8 and 15, subjects will also receive their standard dose of Methotrexate ( a medication being used to treat Rheumatoid Arthritis). Dose level to be decided using data from Parts A, B and C.Parts A and B will be double-blind (i.e. subjects and the investigator will not know who had the study drug) and placebo (dummy medication) controlled. Which participants receive MBS2320 or placebo will be determined randomly.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0385
Date of REC Opinion
3 Jun 2015
REC opinion
Further Information Favourable Opinion