A study of MEDI7352 in Painful Osteoarthritis of the Knee

Study identifier:D5680C00001

ClinicalTrials.gov identifier:NCT02508155

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI7352 in Subjects with Painful Osteoarthritis of the Knee

Medical condition

Chronic Pain

Phase

Phase 1

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

129

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 29 Oct 2015

Primary Completion Date: 23 Dec 2020

Study Completion Date: 23 Dec 2020

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other

Verification:

Verified 01 Dec 2021 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Berlin, Germany, 10117

Location

Research Site

Belfast, United Kingdom, BT2 7BA

Location

Research Site

London, United Kingdom, NW10 7EW

Location

Research Site

Göteborg, Sweden, 413 45

Location

Research Site

Stockholm, Sweden, 141 86

Location

Research Site

Manchester, United Kingdom, M13 9NQ

Arms	Assigned Interventions
Experimental: Part 1 SAD phase MEDI7352 Dose 1 (IV) Participants in Part 1 of SAD phase will receive intravenous (IV) infusion of MEDI7352 Dose 1 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 1 SAD phase MEDI7352 Dose 2 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 2 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 1 SAD phase MEDI7352 Dose 3 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 3 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 1 SAD phase MEDI7352 Dose 4 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 4 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 1 SAD phase MEDI7352 Dose 5 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 5 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 1 SAD phase MEDI7352 Dose 6 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 6 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 1 SAD phase MEDI7352 Dose 4 (SC) Participants in Part 1 of SAD phase will receive subcutaneous (SC) injection of MEDI7352 Dose 4 on Day 1.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Placebo Comparator: Part 1 SAD phase Placebo Participants in Part 1 of SAD phase will receive IV infusion of placebo matched to MEDI7352 on Day 1.	Biological/Vaccine: Placebo Participants will receive placebo matched MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 2 MAD phase MEDI7352 Dose 7 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 7 on Days 1, 15, 29, 43.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 2 MAD phase MEDI7352 Dose 8 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 8 on Days 1, 15, 29, 43.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 2 MAD phase MEDI7352 Dose 4 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 4 on Days 1, 15, 29, 43.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 2 MAD phase MEDI7352 Dose 9 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 9 on Days 1, 15, 29, 43.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Experimental: Part 2 MAD phase MEDI7352 Dose 10 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 10 on Days 1, 15, 29, 43.	Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm.
Placebo Comparator: Part 2 MAD phase Placebo Participants in Part 2 of MAD phase will receive IV infusion of placebo matched to MEDI7352 on Days 1, 15, 29, 43.	Biological/Vaccine: Placebo Participants will receive placebo matched MEDI7352 IV/SC accordingly to the allocated arm.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

David Bell

Biokinetics

A study of MEDI7352 in Painful Osteoarthritis of the Knee

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator