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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198558
• Other study ID #: D7060C00001
• Secondary ID: 2019-002128-33
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2019
• Est. completion date: February 23, 2022

Study information

• Verified date: October 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• MEDI0618
MEDI0618 A novel human immunoglobulin antibody
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-drug antibody incidence and titres	Anti-drug (MEDI0618) antibody incidence and titres	Up to 85 days
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse Events	Up to 85 days
Primary	Incidence of Treatment-Emergent Serious Adverse Events	Serious Adverse Events	Up to 85 days
Primary	Vital Signs	Heart Rate in beats per minute	Up to 85 days
Primary	Vital Signs	Blood pressure in mm Hg	Up to 85 days
Primary	Body Weight	Weight in kg	Up to 85 days
Primary	Height	Height in meters Height and weight will be combined to report BMI in kg/m^2	Up to 85 days
Primary	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
Primary	Haematology	Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin	Up to 85 days
Primary	Thyroid Function	Measurement of Thyroid-stimulating hormone and free thyroxine	Up to 85 days
Primary	Renal Function	Measurement of Glomerular filtration rate	Up to 85 days
Primary	Urinalysis	Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine	Up to 85 days
Primary	12-Lead Electrocardiogram	Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings	Up to 85 days
Primary	Physical Examination	General physical examination	Up to 85 days
Secondary	Peak plasma concentration (Cmax)	Peak concentration of MEDI0618 in plasma	Up to 85 days
Secondary	Time to maximum concentration (tmax)	Time to maximum concentration of MEDI0618 in plasma	Up to 85 days
Secondary	Area under the concentration versus time curve (AUC)	Calculated area under the concentration versus time curve for MEDI0618	Up to 85 days
Secondary	Terminal half-life	Time required for the plasma concentration of MEDI0618 to decrease by 50%	Up to 85 days
Secondary	Bioavailability	The fraction of MEDI0618 administered that is available to the systemic circulation	Up to 85 days

External Links

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