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

NCT04198558

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Chronic Pain

Interventions: MEDI0618, Placebo

Countries: Germany

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

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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)
  • Berlin, Germany