Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants

NCT05070312 | Completed Phase 1

• 1 other identifier: D9182C00002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants.

Conditions

Healthy Volunteer

Keywords

MEDI3506; Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• Maximum observed concentration (Cmax)

  To assess the maximum plasma concentration of MEDI3506 after single subcutaneous administrations in healthy Chinese participants.

  Day 1 to Day 113

• Area under the serum concentration time curve to the infinite (AUC0-inf)

  To assess the area under the serum concentration time curve from pre-dose until infinite after single Subcutaneous administration of MEDI3506 in healthy Chinese participants

  Day 1 to Day 113

• Area under the serum concentration time curve to the last observation(AUC0-t)

  To assess the area under the serum concentration time curve from pre-dose until the last observation quantified after single Subcutaneous administration of MEDI3506 in healthy Chinese participants

  Day 1 to Day 113

• Terminal Elimination half-life (t1/2)

  To assess the terminal elimination half-life after single Subcutaneous administration of MEDI3506 in healthy Chinese participants

  Day 1 to Day 113

• Apparent total body Clearance (CL/F)

  To evaluate the apparent MEDI3506 total body clearance from serum after single subcutaneous administration of MEDI3506 in healthy Chinese participants

  Day 1 to Day 113

• Apparent volume of distribution based on terminal phase (Vz/F)

  To assess the apparent volume of distribution of MEDI3506 after single subcutaneous administration of MEDI3506 in healthy Chinese participants

  Day 1 to Day 113

• Time to reach maximum observed concentration (tmax)

  To assess the MEDI3506 time to reach peak serum concentration after single subcutaneous administration of MEDI3506 in healthy Chinese participants.

  Day 1 to Day 113

Secondary Outcomes (2)

• Immunogenicity determined by prevalence of antidrug antibodies (ADA)

  Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113

• Immunogenicity determined by incidence of ADA

  Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113

Other Outcomes (12)

• Incidence of treatment-emergent AE

  Day 1 to Day 113

• Incidence of treatment-emergent SAE

  Day 1 to Day 113

• Safety as determined by evaluation of blood pressure in mmHg

  Day 1 to Day 113

Study Arms (3)

MEDI3506 dose 1

EXPERIMENTAL

MEDI3506 dose1

Biological: MEDI3506

MEDI3506 dose 2

EXPERIMENTAL

MEDI3506 dose 2

Biological: MEDI3506

Placebo

PLACEBO COMPARATOR

Placebo 2 mL and 4 mL

Drug: Placebo

Interventions

MEDI3506 BIOLOGICAL

MEDI3506

MEDI3506 dose 1; MEDI3506 dose 2

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Aged 18 to 45 years (inclusive, at the time of signing the ICF).
• Healthy, non smoking Chinese participants. Definition of non-smoker: non-smoker for at least the past 12 months with pack history ≤5 pack years.
• Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
• Have a body mass index between 19 and 24 kg/m2 , inclusive.
• Male and female.
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from enrolment throughout the study until their final follow-up visit. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of child bearing potential must have a negative serum pregnancy test result at Visit 1.
• A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.
• Females not of childbearing potential who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment prior to the planned date of randomization and follicle stimulating hormone (FSH) levels in the postmenopausal range.
• Nonsterilised males who are sexually active with a female partner of childbearing potential must use condom and spermicide from enrolment through the study period until their final follow up visit. Because male condom and spermicide is not a highly effective contraception method, female partners of a male study participants must also use a highly effective method of contraception as defined above throughout this period.

You may not qualify if:

• Any active medical or psychiatric condition or other reason which, in the opinion of the investigator, may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study.
• Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening, and Day 1(pre-dose):
• a. Abnormal vital signs, after 10 minutes supine rest (confirmed by 1 controlled measurement), defined as any of the following: i. Fever greater than 37.5℃ ii. SBP \< 90 mmHg or ≥ 140 mmHg iii. DBP \< 50 mmHg or ≥ 90 mmHg iv. Pulse \< 45 or \> 100 bpm b. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T wave morphology, or left ventricular hypertrophy.
• Any other clinically relevant abnormal findings on physical examination or laboratory testing including haematology, coagulation, clinical chemistry or urinalysis at screening or randomization, which in the opinion of the investigator may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study. Abnormal findings include, but are not limited to:
• Serum alanine transaminase' (ALT) or aspartate transaminase' (AST) \> 2.0 × upper limit of normal (ULN) or total bilirubin (TBL) \> 2 × ULN (unless due to Gilbert's disease) or evidence of chronic liver disease
• Total white blood cell count \< 4,000 × 106/L
• Neutrophil count \< 1,500/mm3
• Platelet count \< 100,000/mm3
• Haemoglobin \< 110 g/L
• History or a reason to believe that a participant has a history of drug or alcohol abuse within the past 2 years prior to screening.
• Positive drugs of abuse (DOA) including morphine, methamphetamine, ketamine, marijuana, methylenedioxymethamphetamin, and alcohol (unless can be explained by the participant's medications).
• Major surgery within 8 weeks prior to screening, or planned inpatient surgery or hospitalization during the study period.
• Donation of blood or blood products in excess of 400 mL within 3 months prior to screening and until the end of the follow-up period \[Day 113\].
• Participants who have a positive test for, or have been treated for hepatitis B, hepatitis C, Syphilis or HIV. Regarding the hepatitis B testing (hepatitis B surface antigen \[HBsAg\], hepatitis B surface antibody \[anti-HBs\], hepatitis B core antibody \[anti-HBc\]), any of the following would exclude the participant from the study:
• Participants positive for HBsAg.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Suzhou, 215006, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: October 7, 2021
• Study Start: August 23, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessor) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (1)