Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers
CompletedPhase 1NCT05714254
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: MEDI0618
- Drug: Placebo
- Sponsor
- AstraZeneca
- Start date
- 2022-12-12
- Primary completion
- 2023-12-12
- Sex
- All
- Age range
- from 18 Years to 50 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Germany
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Healthy men and women of non-child bearing potential * Aged 18 to 50 years, inclusive * Weigh more than 50 kg * Body Mass Index between 18 to 30 kg/m2 * Healthy, in the opinion of the Principal Investigator * Able to understand and comply with the protocol requirements Exclusion Criteria: * Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer * Donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit * Poor venous access * History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics * Prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorder * History of cancer within 5 years of screening * History of drug abuse * Use of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatments * Any clinical abnormality on complete physical examination, vitals signs, ECG or clinical laboratory test results at screening or between screening and randomisation
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05714254