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

NCT ID: NCT05714254

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2023-12-12

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

MEDI0618

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

Group Type: ACTIVE_COMPARATOR

MEDI0618

Intervention Type: DRUG

Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.

Placebo

Histidine/histidine HCl, sucrose and polysorbate

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Four doses of IV placebo or SC placebo administered once every two weeks.

Interventions

MEDI0618

Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.

Intervention Type: DRUG

Placebo

Four doses of IV placebo or SC placebo administered once every two weeks.

Intervention Type: DRUG

Other Intervention Names

Protease-Activated Receptor 2 Antagonist

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanislav Ignatenko

Role: PRINCIPAL_INVESTIGATOR

Charite Research Organisation, Berlin Germany

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D7060C00002

Identifier Type: -

Identifier Source: org_study_id