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Completed

NCT Number: NCT02480946

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

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly inhibit bone damage.The aim of this study is to test the safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in combination with an existing treatment, methotrexate.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Royal Liverpool Clinical Research Unit,Royal Liverpool University Hospital, Liverpool, Merseyside, United Kingdom

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About this study

The study will be conducted in 4 parts (parts A to D). The principal aim of this study is to obtain safety and tolerability data when MBS2320 is administered orally as single and multiple doses to healthy subjects (parts A to C). The effect of MBS2320 on the pharmacokinetics (PK) of the first-line rheumatoid arthritis (RA) therapy, methotrexate (MTX), and the effect of MTX on the PK of MBS2320, will also be evaluated in a cohort consisting of subjects with RA (Part D).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBS2320

Drug

As described in the arm descriptions

Placebo

Drug

As described in the arm descriptions

methotrexate

Drug

Background therapy as described in the arm descriptions

Other names: Rheumatrex, Trexall, Amethoperin, Mexate

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Part D - Peak Plasma Concentration (Cmax) of MBS2320 and methotrexate

    Time frame: During the study treatment period

    Half-life (T1/2)

  5. Part D - Area under the plasma concentration versus time curve (AUC) of MBS2320 and methotrexate

    Time frame: During the study treatment period

    Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time to peak plasma concentration (Tmax), Half-life (T1/2)

  6. Part D - Time to peak plasma concentration (Tmax) of MBS2320 and methotrexate

    Time frame: During the study treatment period

  7. Part D - Half-life (T1/2) of MBS2320 and methotrexate

    Time frame: During the study treatment period

  8. Part D - Early response biomarkers of disease activity and bone turnover

    Time frame: Day 1 and 16.

    CRP and CTX

Sponsors and collaborators

Lead sponsor

Modern Biosciences Ltd

Industry

Collaborators

  • Covance

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 25, 2015
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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