Research Site
Berlin, 10117, Germany
NCT Number: NCT05714254
This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.
Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.
Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Berlin, 10117, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.
Other names: Protease-Activated Receptor 2 Antagonist
Four doses of IV placebo or SC placebo administered once every two weeks.
Time frame: From Screening, Day 1 to Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time frame: From Screening, Day 1 to Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time frame: Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
To characterise the immunogenicity of MEDI0618 administered IV or SC
AstraZeneca
Industry
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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