Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: MEDI0618
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer Donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit Poor venous access History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics Prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorder History of cancer within 5 years of screening History of drug abuse Use of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatments Any clinical abnormality on complete physical examination, vitals signs, ECG or clinical laboratory test results at screening or between screening and randomisation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MEDI0618<br>A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) | Drug: MEDI0618<br>* Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.<br>* Other names: Protease-Activated Receptor 2 Antagonist;|
| Placebo Comparator: Placebo<br>Histidine/histidine HCl, sucrose and polysorbate | Drug: Placebo<br>* Four doses of IV placebo or SC placebo administered once every two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |