Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.
Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.
Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI0618 | Active Comparator | A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) |
|
| Placebo | Placebo Comparator | Histidine/histidine HCl, sucrose and polysorbate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI0618 | Drug | Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | To characterise the safety and tolerability of MEDI0618 administered IV or SC | From Screening, Day 1 to Day 113 |
| Incidence of abnormal vital signs | To characterise the safety and tolerability of MEDI0618 administered IV or SC | From Screening, Day 1 to Day 113 |
| Incidence of abnormal laboratory parameters | To characterise the safety and tolerability of MEDI0618 administered IV or SC | Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed plasma concentration (Tmax) of MEDI0618 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC | Day 1 to Day 113 |
| Maximum observed plasma concentration (Cmax) of MEDI0618 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stanislav Ignatenko | Charite Research Organisation, Berlin Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 10117 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Not provided
Not provided
Double-blind
| Placebo | Drug | Four doses of IV placebo or SC placebo administered once every two weeks. |
|
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
| Day 1 to Day 113 |
| Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC | Day 1 to Day 113 |
| Pre-dose trough concentration (Ctrough) of MEDI0618 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC | Day 1 to Day 113 |
| The volume of plasma cleared of drug per unit time (CL) of MEDI0618 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC | Day 1 to Day 113 |
| Anti-drug antibodies (ADA) | To characterise the immunogenicity of MEDI0618 administered IV or SC | Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113 |