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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-29

Study Completion Date

2022-02-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Double-blind

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MEDI0618

MEDI0618 A novel human immunoglobulin antibody

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes