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

NCT05714254 | Completed Phase 1

• 1 other identifier: D7060C00002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  To characterise the safety and tolerability of MEDI0618 administered IV or SC

  From Screening, Day 1 to Day 113

• Incidence of abnormal vital signs

  To characterise the safety and tolerability of MEDI0618 administered IV or SC

  From Screening, Day 1 to Day 113

• 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 Outcomes (6)

• Time to maximum observed plasma concentration (Tmax) of MEDI0618

  Day 1 to Day 113

• Maximum observed plasma concentration (Cmax) of MEDI0618

  Day 1 to Day 113

• Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618

  Day 1 to Day 113

• Pre-dose trough concentration (Ctrough) of MEDI0618

  Day 1 to Day 113

• The volume of plasma cleared of drug per unit time (CL) of MEDI0618

  Day 1 to Day 113

Study Arms (2)

MEDI0618

ACTIVE COMPARATOR

A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2)

Drug: MEDI0618

Placebo

PLACEBO COMPARATOR

Histidine/histidine HCl, sucrose and polysorbate

Drug: Placebo

Interventions

MEDI0618 DRUG

Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.

Also known as: Protease-Activated Receptor 2 Antagonist

MEDI0618

Placebo DRUG

Four doses of IV placebo or SC placebo administered once every two weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanislav Ignatenko

  Charite Research Organisation, Berlin Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 6, 2023
• Study Start: December 12, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)