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

A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: MEDI0618; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MEDI0618; A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2)	Drug: MEDI0618; Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.; Other Names: Protease-Activated Receptor 2 Antagonist
Placebo Comparator: Placebo; Histidine/histidine HCl, sucrose and polysorbate	Drug: Placebo; Four doses of IV placebo or SC placebo administered once every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	To characterise the safety and tolerability of MEDI0618 administered IV or SC	From Screening, Day 1 to Day 113
Incidence of abnormal vital signs	To characterise the safety and tolerability of MEDI0618 administered IV or SC	From Screening, Day 1 to Day 113
Incidence of abnormal laboratory parameters	To characterise the safety and tolerability of MEDI0618 administered IV or SC	Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum observed plasma concentration (Tmax) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Maximum observed plasma concentration (Cmax) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Pre-dose trough concentration (Ctrough) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
The volume of plasma cleared of drug per unit time (CL) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Anti-drug antibodies (ADA)	To characterise the immunogenicity of MEDI0618 administered IV or SC	Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Stanislav Ignatenko, Charite Research Organisation, Berlin Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: D7060C00002; 2022-002889-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No