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

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

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: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse Events	Up to 85 days
Incidence of Treatment-Emergent Serious Adverse Events	Serious Adverse Events	Up to 85 days
Vital Signs	Heart Rate in beats per minute	Up to 85 days
Vital Signs	Blood pressure in mm Hg	Up to 85 days
Body Weight	Weight in kg	Up to 85 days
Height	Height in meters Height and weight will be combined to report BMI in kg/m^2	Up to 85 days
Clinical Chemistry	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	Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin	Up to 85 days
Thyroid Function	Measurement of Thyroid-stimulating hormone and free thyroxine	Up to 85 days
Renal Function	Measurement of Glomerular filtration rate	Up to 85 days
Urinalysis	Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine	Up to 85 days
12-Lead Electrocardiogram	Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings	Up to 85 days
Physical Examination	General physical examination	Up to 85 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax)	Peak concentration of MEDI0618 in plasma	Up to 85 days
Time to maximum concentration (tmax)	Time to maximum concentration of MEDI0618 in plasma	Up to 85 days
Area under the concentration versus time curve (AUC)	Calculated area under the concentration versus time curve for MEDI0618	Up to 85 days
Terminal half-life	Time required for the plasma concentration of MEDI0618 to decrease by 50%	Up to 85 days
Bioavailability	The fraction of MEDI0618 administered that is available to the systemic circulation	Up to 85 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-drug antibody incidence and titres	Anti-drug (MEDI0618) antibody incidence and titres	Up to 85 days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Tharani Chessell, PhD, AstraZeneca; Principal Investigator: Stanislav Ignatenko, Medical Doctor, Charité Research Organisation

Publications and helpful links

Helpful Links

• CSR SYNOPSIS

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Placebo-controlled; Double-blind; Safety and Tolerability Study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID 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