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
2 other identifiers
interventional
64
1 country
1
Brief Summary
This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 chronic-pain
Started Nov 2019
Typical duration for phase_1 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2019
CompletedStudy Start
First participant enrolled
November 29, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2022
CompletedOctober 16, 2023
October 1, 2023
2.2 years
November 25, 2019
October 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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 Outcomes (5)
Peak plasma concentration (Cmax)
Up to 85 days
Time to maximum concentration (tmax)
Up to 85 days
Area under the concentration versus time curve (AUC)
Up to 85 days
Terminal half-life
Up to 85 days
Bioavailability
Up to 85 days
Other Outcomes (1)
Anti-drug antibody incidence and titres
Up to 85 days
Study Arms (9)
Dose Level 1
EXPERIMENTALMEDI0618 or placebo
Dose Level 2
EXPERIMENTALMEDI0618 or placebo
Dose Level 3
EXPERIMENTALMEDI0618 or placebo
Dose Level 4
EXPERIMENTALMEDI0618 or placebo
Dose Level 5
EXPERIMENTALMEDI0618 or placebo
Dose Level 6
EXPERIMENTALMEDI0618 or placebo
Dose Level 7
EXPERIMENTALMEDI0618 or placebo
Dose Level 8
EXPERIMENTALMEDI0618 or placebo
Dose Level 9
EXPERIMENTALMEDI0618 or placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Berlin, 10117, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tharani Chessell, PhD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Stanislav Ignatenko, Medical Doctor
Charite Research Organisation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2019
First Posted
December 13, 2019
Study Start
November 29, 2019
Primary Completion
February 23, 2022
Study Completion
February 23, 2022
Last Updated
October 16, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After CSR sign-off.
- Access Criteria
- Qualified researchers.
Anonymised individual patient-level data will be shared.