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MEDI7734 · 1 trial · 1 indication
The safety and tolerability of MEDI7734 as measured by the incidence of any adverse events that occur on or after the day of administration of investigational product through the end of follow-up. Laboratory measurements, vital sign measurements, and electrocardiogram (ECG) parameters will also be evaluated as part of safety.
| Arm | Type | Description |
|---|---|---|
| MEDI7734 | ACTIVE_COMPARATOR | Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects. |
| Placebo | PLACEBO_COMPARATOR | One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects. |
| Name | Type | Description |
|---|---|---|
| MEDI7734 | BIOLOGICAL | Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects. |
| Placebo | BIOLOGICAL | One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects. |
Key Inclusion Criteria: 1. Age 18-65 years old 2. Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria. 3. Weight 40-120kg 4. Stable disease such that in the opinion of the investigator it is unlikely that a...
MEDI7734 is an investigational monoclonal antibody being studied for the treatment of type I interferon-mediated autoimmune diseases, including dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). It is being developed by Amgen Inc. for these immunology indications.
MEDI7734 is a monoclonal antibody designed to target type I interferon-mediated pathways involved in autoimmune diseases. It is being investigated for conditions such as dermatomyositis, polymyositis, Sjogren's syndrome, SLE, and SSc, where type I interferons play a role in disease pathogenesis.
MEDI7734 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical development for type I interferon-mediated autoimmune diseases.
MEDI7734 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its safety and tolerability in patients with type I interferon-mediated autoimmune diseases.
MEDI7734 has one completed Phase 1 clinical trial, identified as NCT02780674, titled 'A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases.' The study enrolled 36 participants in the United States and was a randomized, double-blind, placebo-controlled trial.
MEDI7734 is the primary name for this investigational monoclonal antibody. No alternative names have been reported for this drug in clinical development. It is being studied under this identifier in clinical trials for autoimmune diseases.