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

  • STATUS
    Recruiting
  • days left to enroll
    38
  • participants needed
    70
  • sponsor
    AstraZeneca
Updated on 4 August 2021

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.

Details
Condition Pain, Chronic Pain, Post-Surgical Pain, Pain (Pediatric), chronic pains
Treatment Placebo, MEDI0618
Clinical Study IdentifierNCT04198558
SponsorAstraZeneca
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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