Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02780674 | A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases | PHASE1 | COMPLETED | 36 | — | — | Aug 26, 2016 | Nov 27, 2017 | Dec 13, 2024 | 7 | United States |
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...