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NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease

ConditionGraves Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMerida Biosciences

About this trial

The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 to 65 years of age, inclusive, at the time of signing the ICF

Documented GD diagnosis,

Receiving stable dose of ATD (Antithyroid drug)

Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive

Disqualifiers

total thyroidectomy.

History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter).

History of thyroid storm.

History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity due to prior ATD therapy Treatment with RAI therapy within 12 months prior to Screening

Trial design

Design model

Sequential

Treatments tested in this trial

  • MER511 (IV)

    Biological/Vaccine

    Participants will receive a single dose of MER511 on Day 1

  • Placebo comparator (IV)

    Biological/Vaccine

    Participants will receive a single dose of Placebo on Day 1

  • MER511 (SC)

    Biological/Vaccine

    Participants will receive a single dose of MER511 on Day 1

  • Placebo comparator (SC)

    Biological/Vaccine

    Participants will receive a single dose of Placebo on Day 1

  • MER511 (SC) for MAD

    Biological/Vaccine

    Participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29

  • Placebo comparator (SC) for MAD

    Biological/Vaccine

    Participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A (SAD) MER511 IVExperimental treatment 1 intervention
Group B: Part A (SAD) placebo IVPlacebo comparator 1 intervention
Group C: Part A (SAD) MER511 SCExperimental treatment 1 intervention
Group D: Part A (SAD) placebo SCPlacebo comparator 1 intervention
Group E: Part B (MAD) MER511 SCExperimental treatment 1 intervention
Group F: - Part B (MAD) placebo SCPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with TEAEs (Treatment-emergent adverse events)

Adverse events that start or worsen in severity after the start of study drug will be categorized as TEAEs

Time frame
- Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
2

Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination

Incidence of clinically significant abnormalities in ECGs, vital signs, clinical laboratory values, and physical examination

Time frame
- Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24

Secondary outcomes

1

Serum Cmax (Maximum observed concentration)

Measurement of the maximum observed concentration

Time frame
- Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) through Week 16- Part B (MAD) Cohorts: Day 1 (Week 0 dosing Day) Through Week 24
2

Serum tmax (Time to maximum concentration)

Measurement of the time to maximum observed concentration

Time frame
- Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 16 - Part B (MAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 24
3

Serum AUCinf (area under concentration-time curve from time zero to infinity)

Measurement of area under concentration-time curve from time zero to infinity

Time frame
Part A (SAD) Only: Day 1 (Week 0) Dosing Through Week 16
4

Serum AUC0-tau (area under concentration-time curve during the dosing interval)

Measurement of area under concentration-time curve during the dosing interval

Time frame
Part B (MAD) Only: Day 1 (Week 0) Dosing Through Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merida Biosciences

Lead sponsor

Source ClinicalTrials.gov
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