A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.

Detailed Description
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This is a randomised, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers. This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous administration.All subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.

Official Title
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A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single 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-childbearing potential aged 18 to 55 years Normal 12-lead ECG at screening and on day of dosing Physical examinations with no significant findings at screening Be able to understand and comply with protocol requirements Exclusion Criteria: Participation in another clinical study with an investigational product (IP) within half-lives of the IP or 3 months, whichever is longer, prior to screening Requires treatment with another biological therapeutic agent Inability to comply with study-related requirements History of severe allergy or hypersensitivity reactions History of significant psychiatric disorder Presence of any clinically significant illness History of cancer Any clinically important abnormality physical examination, vital signs, ECG or laboratory test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level 1<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 2<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 3<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 4<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 5<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 6<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 7<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 8<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Dose Level 9<br>MEDI0618 or placebo | Drug: MEDI0618<br>* MEDI0618 A novel human immunoglobulin antibody<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse Events | Up to 85 days | 
| Incidence of Treatment-Emergent Serious Adverse Events | Serious Adverse Events | Up to 85 days | 
| Vital Signs | Heart Rate in beats per minute | Up to 85 days | 
| Vital Signs | Blood pressure in mm Hg | Up to 85 days | 
| Body Weight | Weight in kg | Up to 85 days | 
| Height | Height in meters Height and weight will be combined to report BMI in kg/m^2 | Up to 85 days | 
| Clinical Chemistry | 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 | Up to 85 days | 
| Haematology | Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin | Up to 85 days | 
| Thyroid Function | Measurement of Thyroid-stimulating hormone and free thyroxine | Up to 85 days | 
| Renal Function | Measurement of Glomerular filtration rate | Up to 85 days | 
| Urinalysis | Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine | Up to 85 days | 
| 12-Lead Electrocardiogram | Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings | Up to 85 days | 
| Physical Examination | General physical examination | Up to 85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) | Peak concentration of MEDI0618 in plasma | Up to 85 days | 
| Time to maximum concentration (tmax) | Time to maximum concentration of MEDI0618 in plasma | Up to 85 days | 
| Area under the concentration versus time curve (AUC) | Calculated area under the concentration versus time curve for MEDI0618 | Up to 85 days | 
| Terminal half-life | Time required for the plasma concentration of MEDI0618 to decrease by 50% | Up to 85 days | 
| Bioavailability | The fraction of MEDI0618 administered that is available to the systemic circulation | Up to 85 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double-blind, Placebo-controlled, Safety and Tolerability Study, Healthy Volunteers