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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Drug: Placebo; Drug: MEDI0618

Study type: Interventional

Funder types: Industry

Identifiers

NCT04198558

2019-002128-33 (EudraCT Number)

D7060C00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 9 patient groups

Dose Level 1

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 2

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 3

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 4

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 5

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 6

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 7

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 8

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618

Dose Level 9

Experimental group

Description:

MEDI0618 or placebo

Treatment:

Drug: Placebo

Drug: MEDI0618