Clinical trial NCT05714254: Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: From Screening, Day 1 to Day 113
measure: Incidence of abnormal vital signs
timeFrame: From Screening, Day 1 to Day 113
measure: Incidence of abnormal laboratory parameters
timeFrame: Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Secondary outcomes:
measure: Time to maximum observed plasma concentration (Tmax) of MEDI0618
timeFrame: Day 1 to Day 113
measure: Maximum observed plasma concentration (Cmax) of MEDI0618
timeFrame: Day 1 to Day 113
measure: Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618
timeFrame: Day 1 to Day 113
measure: Pre-dose trough concentration (Ctrough) of MEDI0618
timeFrame: Day 1 to Day 113
measure: The volume of plasma cleared of drug per unit time (CL) of MEDI0618
timeFrame: Day 1 to Day 113
measure: Anti-drug antibodies (ADA)
timeFrame: Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: Charite Research Organisation, Berlin Germany
name: Stanislav Ignatenko
role: PRINCIPAL_INVESTIGATOR
References: