Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers
- Registration Number
- NCT05714254
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MEDI0618 MEDI0618 A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) Placebo Placebo Histidine/histidine HCl, sucrose and polysorbate
- Primary Outcome Measures
Name Time Method 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
Incidence of adverse events From Screening, Day 1 to Day 113 To characterise the safety and tolerability of MEDI0618 administered IV or SC
- Secondary Outcome Measures
Name Time Method 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
Pre-dose trough concentration (Ctrough) 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
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
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
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
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany