Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714254
• Other study ID #: D7060C00002
• Status: Completed
• Phase: Phase 1
• Start date: December 12, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• MEDI0618
Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.
• Placebo
Four doses of IV placebo or SC placebo administered once every two weeks.

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	To characterise the safety and tolerability of MEDI0618 administered IV or SC	From Screening, Day 1 to Day 113
Primary	Incidence of abnormal vital signs	To characterise the safety and tolerability of MEDI0618 administered IV or SC	From Screening, Day 1 to Day 113
Primary	Incidence of abnormal laboratory parameters	To characterise the safety and tolerability of MEDI0618 administered IV or SC	Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Secondary	Time to maximum observed plasma concentration (Tmax) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Secondary	Maximum observed plasma concentration (Cmax) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Secondary	Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Secondary	Pre-dose trough concentration (Ctrough) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Secondary	The volume of plasma cleared of drug per unit time (CL) of MEDI0618	To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC	Day 1 to Day 113
Secondary	Anti-drug antibodies (ADA)	To characterise the immunogenicity of MEDI0618 administered IV or SC	Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113