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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04365218 | A Study to Evaluate the Safety and Pharmacokinetics With MEDI8367 Administered in Healthy Subjects, and in Subjects With Chronic Kidney Disease | PHASE1 | COMPLETED | 12 | — | — | Jul 22, 2020 | Jan 3, 2021 | Apr 21, 2022 | 1 | United States |
To assess AEs as a variable of safety and tolerability of SC of MEDI8367
To assess supine position SBP as a variable of safety and tolerability of MEDI8367
To assess supine position DBP as a variable of safety and tolerability of MEDI8367
To assess change in supine position HR as a variable of safety and tolerability of MEDI8367
To assess change in supine position respiratory rate as a variable of safety and tolerability of MEDI8367
To assess change in oral body temperature as a variable of safety and tolerability of MEDI8367
To assess electrical activity changes in ECG as a variable of safety and tolerability of MEDI8367
To assess change in physical examination as a variable of safety and tolerability of MEDI8367
To assess change in structured neurological assessment as safety and tolerability of MEDI8367. Any new or aggravated clinically relevant abnormal neurological examination finding compared to the baseline assessment will be reported as an AE
To assess retinal imaging as a variable of safety and tolerability of MEDI8367. The presence of proliferative retinopathy or any other new retinal changes will be recorded. Any new or aggravated clinically relevant abnormal retinal imaging finding compared to the baseline assessment will be reported as an AE
To assess change in Hb as a variable of safety and tolerability of MEDI8367
To assess RBC count as a variable of safety and tolerability of MEDI8367
To assess WBC count as a variable of safety and tolerability of MEDI8367
To assess differential WBC count as a variable of safety and tolerability of MEDI8367
To assess HCT as a variable of safety and tolerability of MEDI8367
To assess MCV as a variable of safety and tolerability of MEDI8367
To assess MCH as a variable of safety and tolerability of MEDI8367
To assess reticulocytes absolute count as a variable of safety and tolerability of MEDI8367
To assess MCHC as a variable of safety and tolerability of MEDI8367
To assess platelets count as a variable of safety and tolerability of MEDI8367
To assess creatinine level as a variable of safety and tolerability of MEDI8367
To assess blood urea nitrogen level as a variable of safety and tolerability of MEDI8367
To asses urea level as a variable of safety and tolerability of MEDI8367
To asses bicarbonate level as a variable of safety and tolerability of MEDI8367
To asses CK level as a variable of safety and tolerability of MEDI8367
To asses FSH/LH level for postmenopausal females as a variable of safety and tolerability of MEDI8367
To asses CRP level as a variable of safety and tolerability of MEDI8367
To asses cystatin C level in Cohort 6 only (subjects with CKD) as a variable of safety and tolerability of MEDI8367
To asses glucose (fasting) level as a variable of safety and tolerability of MEDI8367
To assess potassium level as a variable of safety and tolerability of MEDI8367
To assess sodium level as a variable of safety and tolerability of MEDI8367
To assess phosphate level as a variable of safety and tolerability of MEDI8367
To assess calcium level as a variable of safety and tolerability of MEDI8367
To assess chloride level as a variable of safety and tolerability of MEDI8367
To assess ALP level as a variable of safety and tolerability of MEDI8367
To assess bilirubin level as a variable of safety and tolerability of MEDI8367
To assess ALT as a variable of safety and tolerability of MEDI8367
To assess AST as a variable of safety and tolerability of MEDI8367
To assess albumin level as a variable of safety and tolerability of MEDI8367
To assess change in urine protein as a variable of safety and tolerability of MEDI8367
To assess changes in abnormal urine glucose as a variable of safety and tolerability of MEDI8367
To assess change in urine pH as a variable of safety and tolerability of MEDI8367
To assess change in urine ketone as a variable of safety and tolerability of MEDI8367
To assess change in urine bilirubin as a variable of safety and tolerability of MEDI8367
To assess change in urine blood as a variable of safety and tolerability of MEDI8367
To assess change in urine color as a variable of safety and tolerability of MEDI8367 following SC administration of SAD.
To assess change in urine apperance as a variable of safety and tolerability of MEDI8367 following SC administration of SAD.
To assess change in urine specific gravity as a variable of safety and tolerability of MEDI8367
To assess change in urine leukocyte esterase as a variable of safety and tolerability of MEDI8367
To assess change in urine urobilinogen as a variable of safety and tolerability of MEDI8367
To assess change in urine nitrite as a variable of safety and tolerability of MEDI8367
To assess change in urine microscopy included RBC as a variable of safety and tolerability of MEDI8367
To assess change in urine microscopy included WBC as a variable of safety and tolerability of MEDI8367
To assess change in urine microscopy casts as a variable of safety and tolerability of MEDI8367
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Dose A) | EXPERIMENTAL | 6 subjects will be randomized to receive MEDI8367 Dose A and 2 subjects will be randomized to receive placebo. |
| Cohort 2 (Dose B) | EXPERIMENTAL | 6 subjects will be randomized to receive MEDI8367 Dose B and 2 subjects will be randomized to receive placebo. |
| Cohort 3 (Dose C) | EXPERIMENTAL | 6 subjects will be randomized to receive MEDI8367 Dose C and 2 subjects will be randomized to receive placebo. |
| Cohort 4 (Dose D) | EXPERIMENTAL | 6 subjects will be randomized to receive MEDI8367 Dose D and 2 subjects will be randomized to receive placebo. |
| Cohort 5 (Dose D) | EXPERIMENTAL | 6 subjects will be randomized to receive MEDI8367 Dose D or the highest tolerable dose based on Cohorts 1 to 4 and 2 subjects will be randomized to receive placebo. |
| Cohort 6 (Dose D) | EXPERIMENTAL | 15 subjects will be randomized to receive MEDI8367 Dose D or the highest tolerable dose based on Cohorts 1 to 4 and 15 subjects will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| MEDI8367 | DRUG | Subjects will receive subcutaneous (SC) single dose of MEDI8367, depending upon dose escalation strategy and Safety Review Committee results. The maximum dose will not exceed 600 mg. The dose will be administered as a single injection or multiple injections in the abdomen region. |
| Placebo | DRUG | Saline solution for injection and the placebo volume to be administered will be equivalent to the MEDI8367 volume administered for each dosing cohort. |
Inclusion Criteria: * Provision of signed and dated, written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA) prior to any study specific procedures. * Male and/or female subjects aged 18 to 55 years (for Cohort 6 see below...