A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
MEDI0618
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Double-blind, Placebo-controlled, Safety and Tolerability Study, Healthy Volunteers
Eligibility Criteria
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose Level 1
Dose Level 2
Dose Level 3
Dose Level 4
Dose Level 5
Dose Level 6
Dose Level 7
Dose Level 8
Dose Level 9
Arm Description
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
MEDI0618 or placebo
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events
Incidence of Treatment-Emergent Serious Adverse Events
Serious Adverse Events
Vital Signs
Heart Rate in beats per minute
Vital Signs
Blood pressure in mm Hg
Body Weight
Weight in kg
Height
Height in meters Height and weight will be combined to report BMI in kg/m^2
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
Haematology
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Thyroid Function
Measurement of Thyroid-stimulating hormone and free thyroxine
Renal Function
Measurement of Glomerular filtration rate
Urinalysis
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
12-Lead Electrocardiogram
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Physical Examination
General physical examination
Secondary Outcome Measures
Peak plasma concentration (Cmax)
Peak concentration of MEDI0618 in plasma
Time to maximum concentration (tmax)
Time to maximum concentration of MEDI0618 in plasma
Area under the concentration versus time curve (AUC)
Calculated area under the concentration versus time curve for MEDI0618
Terminal half-life
Time required for the plasma concentration of MEDI0618 to decrease by 50%
Bioavailability
The fraction of MEDI0618 administered that is available to the systemic circulation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04198558
Brief Title
A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 2022 (Actual)
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 randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Double-blind, Placebo-controlled, Safety and Tolerability Study, Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 3
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 4
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 5
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 6
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 7
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 8
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Arm Title
Dose Level 9
Arm Type
Experimental
Arm Description
MEDI0618 or placebo
Intervention Type
Drug
Intervention Name(s)
MEDI0618
Intervention Description
MEDI0618 A novel human immunoglobulin antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Adverse Events
Time Frame
Up to 85 days
Title
Incidence of Treatment-Emergent Serious Adverse Events
Description
Serious Adverse Events
Time Frame
Up to 85 days
Title
Vital Signs
Description
Heart Rate in beats per minute
Time Frame
Up to 85 days
Title
Vital Signs
Description
Blood pressure in mm Hg
Time Frame
Up to 85 days
Title
Body Weight
Description
Weight in kg
Time Frame
Up to 85 days
Title
Height
Description
Height in meters Height and weight will be combined to report BMI in kg/m^2
Time Frame
Up to 85 days
Title
Clinical Chemistry
Description
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
Time Frame
Up to 85 days
Title
Haematology
Description
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Time Frame
Up to 85 days
Title
Thyroid Function
Description
Measurement of Thyroid-stimulating hormone and free thyroxine
Time Frame
Up to 85 days
Title
Renal Function
Description
Measurement of Glomerular filtration rate
Time Frame
Up to 85 days
Title
Urinalysis
Description
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Time Frame
Up to 85 days
Title
12-Lead Electrocardiogram
Description
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Time Frame
Up to 85 days
Title
Physical Examination
Description
General physical examination
Time Frame
Up to 85 days
Secondary Outcome Measure Information:
Title
Peak plasma concentration (Cmax)
Description
Peak concentration of MEDI0618 in plasma
Time Frame
Up to 85 days
Title
Time to maximum concentration (tmax)
Description
Time to maximum concentration of MEDI0618 in plasma
Time Frame
Up to 85 days
Title
Area under the concentration versus time curve (AUC)
Description
Calculated area under the concentration versus time curve for MEDI0618
Time Frame
Up to 85 days
Title
Terminal half-life
Description
Time required for the plasma concentration of MEDI0618 to decrease by 50%
Time Frame
Up to 85 days
Title
Bioavailability
Description
The fraction of MEDI0618 administered that is available to the systemic circulation
Time Frame
Up to 85 days
Other Pre-specified Outcome Measures:
Title
Anti-drug antibody incidence and titres
Description
Anti-drug (MEDI0618) antibody incidence and titres
Time Frame
Up to 85 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tharani Chessell, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stanislav Ignatenko, Medical Doctor
Organizational Affiliation
Charite Research Organisation
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
Yes
IPD Sharing Plan Description
Anonymised individual patient-level data will be shared.
IPD Sharing Time Frame
After CSR sign-off.
IPD Sharing Access Criteria
Qualified researchers.
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7060C00001&attachmentIdentifier=a34c53be-52e3-4161-9a92-fec1c1c2e7f1&fileName=CSR_SYNOPSIS_D7060C00001_Version_1.0_final-synopsis-Redacted_06Mar2023.pdf&versionIdentifier=
Description
CSR SYNOPSIS
Learn more about this trial
A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
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