Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI7352 in Healthy Volunteers

Study identifier:D5680C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2020-005982-14

CTIS identifier:N/A

Study Complete

Official 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

Medical condition

Painful osteoarthritis of the knee

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI7352, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 20 Apr 2021

Primary Completion Date: 02 Dec 2021

Study Completion Date: 02 Dec 2021

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy male or female of non childbearing potential participants aged 18 to 65 (inclusive) years for Caucasian participants and 20 to 65 (inclusive) years for Japanese participants with suitable veins for cannulation or repeated venepuncture
• Japanese or Caucasian ethnicity
• Post-menopausal women must have had ≥ 12 months of spontaneous amenorrhea with an follicle stimulating hormone (FSH) concentration consistently ≥ 40 mIU/mL and a negative serum or urine pregnancy test result at Screening or Day -1. Surgically sterile women must have had a hysterectomy, and bilateral ovariectomy (oophorectomy), must provide documentation of the procedure and have had a negative serum or urine pregnancy test at Screening or Day -1. An intermediate or positive pregnancy test, can be confirmed by repeating the pregnancy test and
demonstrating non-doubling of β-human chorionic gonadotropin levels every 48 to 72 hours
• Men who are biologically capable of fathering children must agree and
commit to use of an adequate form of a highly effective method of
contraception and refrain from sperm donation for the duration of the
Treatment Period and for 3 months after the last administration of study
treatment
• Body mass index 18 and 30 kg/m^2, weight at least 50 kg
• No clinically significant abnormality identified on medical or laboratory
evaluation at Screening unless the Investigator considers that the
finding will not introduce additional risk factors and will not interfere
with the study procedures
• 12-lead electrocardiogram recorded at Screening and Day -1 that is normal for the age group and shows no significant abnormalities that will compromise safety
• Physical examinations with no significant findings at Screening and on
Day -1.

Exclusion Criteria

• Participation in another clinical study or use of any experimental
medication, device, or biologic with an investigational product (IP) within 5 half-lives of that IP or 3 months (whichever is longer) prior to first dosing
• Participation in another study investigating any form of anti-NGF or anti-TNF therapy in the 6 months prior to Screening and until after the final Follow-up Visit
• Any positive laboratory result at screening for COVID-19
• Blood donation or draw in excess of 400 mL within 2 months prior to Screening or plasma donation in excess of 50 mL within 30 prior to Screening
• Inability to comply with study-related restrictions and requirements related to consumption of alcohol, provision of meals and snacks, nicotine use, activity, blood donation, and contraception
• History of severe allergy/hypersensitivity reactions or ongoing severe
allergy/hypersensitivity reactions, or history of hypersensitivity to immunizations or immunoglobulins or other biological modalities
• History of any significant psychiatric disorder
• Any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic, rheumatologic or endocrine disease or disorder
• Recent (within the last 3 months) or active infection considered to be clinically significant, or any infection for which there are unresolved medical sequelae
• Clinically significant osteoarthritis (OA) currently affecting a major
joint in the upper or lower extremity or axial spine; or other degenerative disease affecting any joint in participants for whom, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy; or history of trauma or surgery involving any major joint or axial spine
• Radiological significant abnormalities reported on baseline MRI of hips and knees that are considered to present a risk of osteonecrosis, rapidly progressive OA, subchondral insufficiency fractures; or other coincidental finding(s) that present a risk to the safety or welfare of the participant
• History of excessive alcohol intake
• History of cancer within 5 years, with the exception of non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix or non-progressive prostate cancer
• History of drug abuse or positive test for drugs of abuse or alcohol
• Use of prescription or non-prescription drugs, including vitamins and
herbal and dietary supplements, within 7 days or 5 half-lives of the drug (whichever is longer) prior to the administration of study treatment
• Any clinically important or significant abnormality on a physical examination, vital signs, ECG or clinical laboratory test results that could be detrimental to participant safety or compromise the study
• Positive serologic findings at Screening for Human immunodeficiency
virus antibodies, hepatitis B surface antigen or hepatitis C virus antibodies
• Positive QuantiFERON test for tuberculosis
• Any minor medical or surgical procedure or trauma within 28 days of Day 1 or planned surgical procedure during the study.

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1: Japanese MEDI7352 Randomized Japanese participants will receive single doses of MEDI7352 subcutaneously.	Drug: MEDI7352 A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions.
Placebo Comparator: Cohort 1: Japanese Placebo Randomized Japanese participants will receive matching placebo subcutaneously.	Drug: Placebo Matching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions.
Experimental: Cohort 2: Caucasian MEDI7352 Randomized Caucasian participants will receive single doses of MEDI7352 subcutaneously.	Drug: MEDI7352 A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions.
Placebo Comparator: Cohort 2: Caucasian Placebo Randomized Caucasian participants will receive matching placebo subcutaneously.	Drug: Placebo Matching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions.

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]