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OpenTrials
Completed

NCT Number: NCT05714254

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI0618

Drug

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

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Time to maximum observed plasma concentration (Tmax) of MEDI0618

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 1 to Day 113

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

  6. Anti-drug antibodies (ADA)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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