Evaluate Safety, Tolerability, PK and Immunogenicity of MEDI7352 in HV
Research type
Research Study
Full title
A Randomised, Double blind, Placebo controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Doses of MEDI7352 Administered by the Subcutaneous Route in Healthy Japanese and Caucasian Subjects
IRAS ID
293199
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2020-005982-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
This clinical study is a randomised, double blind, placebo-controlled study in healthy Japanese and Caucasian male subjects and female subjects of non-childbearing potential that is performed at a single study centre.
The main aim of the study is to evaluate the safety, tolerability, pharmacokinetics (amount of drug in the body over time), and immunogenicity of multiple fixed doses of MEDI7352 administered subcutaneously (sc). Inclusion of Japanese and Caucasian subjects may support the participation of Japanese subjects in ongoing and planned studies.
Altogether 20 subjects (10 Caucasian and 10 Japanese) will be included. The study duration for each participant will be approximately 17 weeks.
The study consists of a Screening Period of up to 36 days (including a washout of 7 days of any prohibited medications before first dosing), a Treatment Period of 6 weeks during which the subjects will be given 1 dose of 150 mg MEDI7352 or placebo every 2 weeks (4 doses in total), and a Follow up Period of 6 weeks with multiple ambulatory visits, and a final Follow-up Visit 42 days after the Treatment Period. Subjects will be required to stay in the Clinical Unit from the day before each dosing day until at least 8 hours after dosing.
This is not a first-in-human study as the study drug has already been given to patients with osteoarthritis (OA) of the knee and painful diabetic neuropathy (PDN) in 2 clinical studies (1 completed, 1 ongoing). As of 08 January 2021, an estimated 109 subjects (data still blinded) have received at least one dose of MEDI7352 with most doses administered intravenously and a small number of subjects (6) having received single doses of MEDI7352 (50 µg) administered sc.
The study drug is being developed by the sponsor for the symptomatic treatment of chronic painful conditions including OA and PDN.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0004
Date of REC Opinion
25 Mar 2021
REC opinion
Further Information Favourable Opinion