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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Drug: MEDI0618; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05714254

D7060C00002

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

MEDI0618

Active Comparator group

Description:

A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2)

Treatment:

Drug: MEDI0618

Placebo

Placebo Comparator group

Description:

Histidine/histidine HCl, sucrose and polysorbate

Treatment:

Drug: Placebo