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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05714254 | Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers | PHASE1 | COMPLETED | 36 | — | — | Dec 12, 2022 | Dec 12, 2023 | Jan 5, 2024 | 1 | Germany |
| NCT04198558 | A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers | PHASE1 | COMPLETED | 64 | — | — | Nov 29, 2019 | Feb 23, 2022 | Oct 16, 2023 | 1 | Germany |
To characterise the safety and tolerability of MEDI0618 administered IV or SC
To characterise the safety and tolerability of MEDI0618 administered IV or SC
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Adverse Events
Serious Adverse Events
Heart Rate in beats per minute
Weight in kg
Height in meters Height and weight will be combined to report BMI in kg/m\^2
Measurement of Albumin, Protein, Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, Bilirubin, Calcium, Creatine phosphokinase, C-reactive protein, Glucose, Blood urea nitrogen, Phosphate, Potassium, Sodium, Chloride and Bicarbonate
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Measurement of Thyroid-stimulating hormone and free thyroxine
Measurement of Glomerular filtration rate
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
General physical examination
| Arm | Type | Description |
|---|---|---|
| MEDI0618 | ACTIVE_COMPARATOR | A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) |
| Placebo | PLACEBO_COMPARATOR | Histidine/histidine HCl, sucrose and polysorbate |
| Dose Level 1 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 2 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 3 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 4 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 5 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 6 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 7 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 8 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 9 | EXPERIMENTAL | MEDI0618 or placebo |
| Name | Type | Description |
|---|---|---|
| MEDI0618 | DRUG | Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks. |
| Placebo | DRUG | Four doses of IV placebo or SC placebo administered once every two weeks. |
Inclusion Criteria: * Healthy men and women of non-child bearing potential * Aged 18 to 50 years, inclusive * Weigh more than 50 kg * Body Mass Index between 18 to 30 kg/m2 * Healthy, in the opinion of the Principal Investigator * Able to understand and comply with the protocol requirements Exclus...