Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02480946
• Date of registration: 16/06/2015
• Prospective Registration: Yes
• Primary sponsor: Modern Biosciences plc
• Public title: Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis
• Scientific title: A Four-Part Phase-1 Study Investigating the Tolerability, Safety and Pharmacokinetics (PK) of MBS2320 in Healthy Subjects and in Subjects With Rheumatoid Arthritis (RA) Also Treated With Methotrexate
• Date of first enrolment: July 2015
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02480946
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Jim Bush, MBChB,PhD
• Affiliation: Covance

Key inclusion & exclusion criteria

Principal Inclusion Criteria:

Parts A, B, and C.

- Healthy males or females between 18 and 60 years of age.

- A body mass index (BMI) between 18.0 and 30.0 kg/m2.

- Female subjects will be of non-childbearing potential or postmenopausal as defined by
the protocol.

- Female subjects must not be pregnant.

Part D

- Subjects will be otherwise healthy males or females with a diagnosis of RA between 18
and 70 years of age.

- Subjects will have a BMI between 18.0 and 30.0 kg/m2.

- Female subjects must not be pregnant.

- Subjects must have been treated with, and tolerated, oral or subcutaneous MTX for a
minimum of 3 months prior to screening entry.

Principal Exclusion Criteria:

Parts A, B, and C.

- Male subjects who do not agree to use appropriate contraception.

- Female subjects who are receiving HRT who do not agree to use appropriate
contraception.

- Subjects who have donated blood in the 3 months, plasma in the 7 days or platelets in
the 6 weeks prior to screening.

- Subjects who consume more than the permitted alcohol requirement, who have a
significant history of alcoholism or drug/chemical abuse.

- Subjects who are unwilling to abstain from alcohol as required.

- A positive urine drug screen, alcohol breath test at screening or first admission.

- Subject has received a live virus vaccination within the 30 days prior to first dose
administration.

- Subjects with a positive test for tuberculosis.

Additional Part D Exclusions

- Subjects who have received any medication (except MTX) known to chronically alter drug
absorption or elimination processes within 30 days prior to the first dose
administration.

- Subjects currently taking any medications other than those allowed per protocol
guidelines.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Methotrexate

Drug: MBS2320

Drug: Placebo

Primary Outcome(s)

Safety and tolerability (incidence of all grade adverse events and dose limiting toxicities during the observation period and/or study treatment periods) [Time Frame: Within 7 days]

Secondary Outcome(s)

Study Parts A, B and C - Area under the plasma concentration versus time curve (AUC) of MBS2320 [Time Frame: Part A and C - Up to 72hrs post dose, Part B - Up to 72 hrs post day 14 dose]

Part D - Early response biomarkers of disease activity and bone turnover [Time Frame: Day 1 and 16.]

Part D - Half-life (T1/2) of MBS2320 and methotrexate [Time Frame: During the study treatment period]

Study Parts A, B and C - Peak Plasma Concentration (Cmax) of MBS2320 [Time Frame: Part A and C - Up to 72hrs post dose, Part B - Up to 72 hrs post day 14 dose]

Part D - Area under the plasma concentration versus time curve (AUC) of MBS2320 and methotrexate [Time Frame: During the study treatment period]

Study Parts A, B and C Time to peak plasma concentration (Tmax) of MBS2320 [Time Frame: Part A and C - Up to 72hrs post dose, Part B - Up to 72 hrs post day 14 dose]

Part D - Peak Plasma Concentration (Cmax) of MBS2320 and methotrexate [Time Frame: During the study treatment period]

Part D - Time to peak plasma concentration (Tmax) of MBS2320 and methotrexate [Time Frame: During the study treatment period]

Secondary ID(s)

120011A

2015-001474-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Covance