A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers

October 13, 2023 updated by: AstraZeneca

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

This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomised, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers.

This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous administration.All subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women of non-childbearing potential aged 18 to 55 years
  • Normal 12-lead ECG at screening and on day of dosing
  • Physical examinations with no significant findings at screening
  • Be able to understand and comply with protocol requirements

Exclusion Criteria:

  • Participation in another clinical study with an investigational product (IP) within half-lives of the IP or 3 months, whichever is longer, prior to screening
  • Requires treatment with another biological therapeutic agent
  • Inability to comply with study-related requirements
  • History of severe allergy or hypersensitivity reactions
  • History of significant psychiatric disorder
  • Presence of any clinically significant illness
  • History of cancer
  • Any clinically important abnormality physical examination, vital signs, ECG or laboratory test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Level 1
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 2
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 3
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 4
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 5
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 6
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 7
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 8
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody
Experimental: Dose Level 9
MEDI0618 or placebo
Drug: Placebo
Placebo
Drug: MEDI0618
MEDI0618 A novel human immunoglobulin antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 85 days
Adverse Events
Up to 85 days
Incidence of Treatment-Emergent Serious Adverse Events
Time Frame: Up to 85 days
Serious Adverse Events
Up to 85 days
Vital Signs
Time Frame: Up to 85 days
Heart Rate in beats per minute
Up to 85 days
Vital Signs
Time Frame: Up to 85 days
Blood pressure in mm Hg
Up to 85 days
Body Weight
Time Frame: Up to 85 days
Weight in kg
Up to 85 days
Height
Time Frame: Up to 85 days
Height in meters Height and weight will be combined to report BMI in kg/m^2
Up to 85 days
Clinical Chemistry
Time Frame: Up to 85 days
Measurement of Albumin, Protein, Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, Bilirubin, Calcium, Creatine phosphokinase, C-reactive protein, Glucose, Blood urea nitrogen, Phosphate, Potassium, Sodium, Chloride and Bicarbonate
Up to 85 days
Haematology
Time Frame: Up to 85 days
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Up to 85 days
Thyroid Function
Time Frame: Up to 85 days
Measurement of Thyroid-stimulating hormone and free thyroxine
Up to 85 days
Renal Function
Time Frame: Up to 85 days
Measurement of Glomerular filtration rate
Up to 85 days
Urinalysis
Time Frame: Up to 85 days
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Up to 85 days
12-Lead Electrocardiogram
Time Frame: Up to 85 days
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Up to 85 days
Physical Examination
Time Frame: Up to 85 days
General physical examination
Up to 85 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax)
Time Frame: Up to 85 days
Peak concentration of MEDI0618 in plasma
Up to 85 days
Time to maximum concentration (tmax)
Time Frame: Up to 85 days
Time to maximum concentration of MEDI0618 in plasma
Up to 85 days
Area under the concentration versus time curve (AUC)
Time Frame: Up to 85 days
Calculated area under the concentration versus time curve for MEDI0618
Up to 85 days
Terminal half-life
Time Frame: Up to 85 days
Time required for the plasma concentration of MEDI0618 to decrease by 50%
Up to 85 days
Bioavailability
Time Frame: Up to 85 days
The fraction of MEDI0618 administered that is available to the systemic circulation
Up to 85 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anti-drug antibody incidence and titres
Time Frame: Up to 85 days
Anti-drug (MEDI0618) antibody incidence and titres
Up to 85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tharani Chessell, PhD, AstraZeneca
  • Principal Investigator: Stanislav Ignatenko, Medical Doctor, Charité Research Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D7060C00001
  • 2019-002128-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised individual patient-level data will be shared.

IPD Sharing Time Frame

After CSR sign-off.

IPD Sharing Access Criteria

Qualified researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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