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Arthritis, RheumatoidPhase 1NCT02480946

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

A Phase 1 study testing MBS2320 and Methotrexate in people with Arthritis, Rheumatoid, run by Modern Biosciences Ltd at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
MBS2320 and Methotrexate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
3 sitesUnited Kingdom
Study dates
Jul 2015to Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Covance Clinical Research Unit Ltd.

    Leeds, West Yorkshire, LS2 9LH

  • Covance Royal Liverpool Clinical Research Unit,Royal Liverpool University Hospital

    Liverpool, Merseyside, L7 8XP

  • NIHR/Wellcome Trust Imperial Clinical Research Facility (CRF)

    London, W12 0HS

Other trials in United Kingdom

About this study

Official 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

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.

Read the detailed description

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).

Being tested
MBS2320, Placebo, Methotrexate
Keywords
Rheumatoid Arthritis, Osteoclastogenesis inhibitor, Anti-Inflammatory Agent, Musculoskeletal Diseases, Joint Diseases
Medical subject headings
Arthritis, Rheumatoid, Musculoskeletal Diseases, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBS2320Drug

    As described in the arm descriptions

  • PlaceboDrug

    As described in the arm descriptions

  • MethotrexateDrug

    Also called Rheumatrex, Trexall, Amethoperin, Mexate

    Background therapy as described in the arm descriptions

Study groups in NCT02480946
Study groupRoleWhat they receive
Single Ascending Dose and Food EffectExperimentalPart A will be a single-dose, sequential-group, double-blind, placebo-controlled study of MBS2320.
Receives: Drug: MBS2320; Drug: Placebo
Multiple Ascending DoseExperimentalPart B will be a multiple-dose, sequential-group, double-blind, placebo-controlled study to investigate 3 planned dose levels.
Receives: Drug: MBS2320; Drug: Placebo
Relative BioavailabilityExperimentalPart C will be an open-label, randomised, 2-period crossover relative bioavailability study of MBS2320 in capsules or suspension. The intention is to enrol 8 healthy subjects. Each subject will participate in 2 treatment periods.
Receives: Drug: MBS2320; Drug: Placebo
Drug-Drug Interaction with MethotrexateExperimentalPart D will be a multiple dose study incorporating an open-label, fixed-sequence drug-drug interaction between MBS2320 and methotrexate and biomarker evaluation.
Receives: Drug: MBS2320; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability (incidence of all grade adverse events and dose limiting toxicities during the observation period and/or study treatment periods)

    Measured: Within 7 days

Secondary outcomes (8)

  1. Study Parts A, B and C - Peak Plasma Concentration (Cmax) of MBS2320

    Measured: 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

    Measured: 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

    Measured: 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

    Half-life (T1/2)

    Measured: During the study treatment period

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

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

    Measured: During the study treatment period

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

    Measured: During the study treatment period

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

    Measured: During the study treatment period

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

    CRP and CTX

    Measured: Day 1 and 16.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480946
Sponsor's protocol ID
120011A
Other IDs
2015-001474-18, 2015
Status last verified
Mar 2017
First submitted
16 Jun 2015
Last updated
28 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MBS2320 and Methotrexate in people with Arthritis, Rheumatoid, run by Modern Biosciences Ltd at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.

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