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

Primary Purpose

Chronic Pain

Status
Active
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
MEDI0618
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MEDI0618

Placebo

Arm Description

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

Histidine/histidine HCl, sucrose and polysorbate

Outcomes

Primary Outcome Measures

Incidence of adverse events
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Incidence of abnormal vital signs
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Incidence of abnormal laboratory parameters
To characterise the safety and tolerability of MEDI0618 administered IV or SC

Secondary Outcome Measures

Time to maximum observed plasma concentration (Tmax) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Maximum observed plasma concentration (Cmax) of MEDI0618
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
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Pre-dose trough concentration (Ctrough) of MEDI0618
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
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Anti-drug antibodies (ADA)
To characterise the immunogenicity of MEDI0618 administered IV or SC

Full Information

First Posted
December 12, 2022
Last Updated
August 24, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05714254
Brief Title
Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDI0618
Arm Type
Active Comparator
Arm Description
A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Histidine/histidine HCl, sucrose and polysorbate
Intervention Type
Drug
Intervention Name(s)
MEDI0618
Other Intervention Name(s)
Protease-Activated Receptor 2 Antagonist
Intervention Description
Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Four doses of IV placebo or SC placebo administered once every two weeks.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time Frame
From Screening, Day 1 to Day 113
Title
Incidence of abnormal vital signs
Description
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time Frame
From Screening, Day 1 to Day 113
Title
Incidence of abnormal laboratory parameters
Description
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time Frame
Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Secondary Outcome Measure Information:
Title
Time to maximum observed plasma concentration (Tmax) of MEDI0618
Description
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time Frame
Day 1 to Day 113
Title
Maximum observed plasma concentration (Cmax) of MEDI0618
Description
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time Frame
Day 1 to Day 113
Title
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618
Description
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time Frame
Day 1 to Day 113
Title
Pre-dose trough concentration (Ctrough) of MEDI0618
Description
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time Frame
Day 1 to Day 113
Title
The volume of plasma cleared of drug per unit time (CL) of MEDI0618
Description
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time Frame
Day 1 to Day 113
Title
Anti-drug antibodies (ADA)
Description
To characterise the immunogenicity of MEDI0618 administered IV or SC
Time Frame
Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislav Ignatenko
Organizational Affiliation
Charite Research Organisation, Berlin Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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