Clincosm LogoSign in Get a demo

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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05714254
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
11.5
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic painProtocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Other
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
Actual Study Start Date :
Dec 12, 2022
Anticipated Primary Completion Date :
Nov 28, 2023
Anticipated Study Completion Date :
Nov 28, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [From Screening, Day 1 to Day 113]

      To characterise the safety and tolerability of MEDI0618 administered IV or SC

    2. Incidence of abnormal vital signs [From Screening, Day 1 to Day 113]

      To characterise the safety and tolerability of MEDI0618 administered IV or SC

    3. 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

    Secondary Outcome Measures

    1. 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

    2. Maximum observed plasma concentration (Cmax) of MEDI0618 [Day 1 to Day 113]

      To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC

    3. 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

    4. Pre-dose trough concentration (Ctrough) of MEDI0618 [Day 1 to Day 113]

      To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Berlin Germany 10117

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05714254
    Other Study ID Numbers:
    • D7060C00002
    • 2022-002889-32
    First Posted:
    Feb 6, 2023
    Last Update Posted:
    Feb 6, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Feb 6, 2023