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

• Status: Recruiting
• Trial end date: 2022-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

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