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

Phase 1CompletedNCT04198558

AstraZeneca64 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Pain

Interventions

MEDI0618DRUG

MEDI0618 A novel human immunoglobulin antibody

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Berlin, Germany

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Adverse Events

Time frame: Up to 85 days

Incidence of Treatment-Emergent Serious Adverse Events

Serious Adverse Events

Time frame: Up to 85 days

Vital Signs

Heart Rate in beats per minute

Time frame: Up to 85 days

Vital Signs

Blood pressure in mm Hg

Time frame: Up to 85 days

Body Weight

Weight in kg

Time frame: Up to 85 days

Height

Height in meters Height and weight will be combined to report BMI in kg/m\^2

Time frame: 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

Time frame: Up to 85 days

Haematology

Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin

Time frame: Up to 85 days

Thyroid Function

Measurement of Thyroid-stimulating hormone and free thyroxine

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Peak plasma concentration (Cmax)

Peak concentration of MEDI0618 in plasma

Time frame: Up to 85 days

Time to maximum concentration (tmax)

Time to maximum concentration of MEDI0618 in plasma

Time frame: Up to 85 days

Area under the concentration versus time curve (AUC)

Calculated area under the concentration versus time curve for MEDI0618

Time frame: Up to 85 days

Terminal half-life

Time required for the plasma concentration of MEDI0618 to decrease by 50%

Time frame: Up to 85 days

Bioavailability

The fraction of MEDI0618 administered that is available to the systemic circulation

Time frame: Up to 85 days