Chronic Pain
Conditions
Brief summary
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.
Interventions
DRUGMEDI0618
Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.
DRUGPlacebo
Four doses of IV placebo or SC placebo administered once every two weeks.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | From Screening, Day 1 to Day 113 | To characterise the safety and tolerability of MEDI0618 administered IV or SC |
| Incidence of abnormal vital signs | From Screening, Day 1 to Day 113 | To characterise the safety and tolerability of MEDI0618 administered IV or SC |
| Incidence of abnormal laboratory parameters | Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113 | To characterise the safety and tolerability of MEDI0618 administered IV or SC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-dose trough concentration (Ctrough) of MEDI0618 | Day 1 to Day 113 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC |
| Time to maximum observed plasma concentration (Tmax) of MEDI0618 | Day 1 to Day 113 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC |
| Anti-drug antibodies (ADA) | Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113 | To characterise the immunogenicity of MEDI0618 administered IV or SC |
| The volume of plasma cleared of drug per unit time (CL) of MEDI0618 | Day 1 to Day 113 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC |
| Maximum observed plasma concentration (Cmax) of MEDI0618 | Day 1 to Day 113 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC |
| Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618 | Day 1 to Day 113 | To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC |
Countries
Germany
Outcome results
None listed