A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
- Registration Number
- NCT06103877
- Lead Sponsor
- AstraZeneca
- Brief Summary
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
- Detailed Description
This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks.
The study will comprise of:
* A Screening Period of maximum 28 days for both Part 1 and Part 2.
* Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days.
* Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days.
* An outpatient Follow-up Period of approximately 15 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 99
- Healthy male and female participants with suitable veins for cannulation or repeated venipuncture
- All females must have a negative pregnancy test
- Females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of contraception
- BMI between 18 and 32 kg/m^2 and weigh at least 45 kg
- Has received another new chemical entity
- History of any disease or disorder which may put participant at risk in the study
- Current or recurrent disease of clinical significance
- Medical history of malignancies except for cervical carcinoma and non-melanoma skin cancer (NMSC)
- Any clinically important illness, medical/procedure, or trauma
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening
- Any positive result on screening for serum hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)
- History of latent or active tuberculosis (TB) or exposure to endemic areas
- Evidence of active TB or untreated/inadequately/inappropriately treated for latent TB
- Positive testing for Covid-19 prior to dosing, case of Covid-19 within 4 weeks, or long-term Covid-19-related sequelae
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG), and any clinically important abnormalities in the 12-lead ECG
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Cohort 1 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 3 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Pooled Placebo SAD IV Placebo Participants will receive matching IV infusion of placebo on Day 1. Part 1 Placebo SAD SC Placebo Participants will receive matching SC injection of placebo on Day 1. Part 1 Placebo SAD (Chinese Participants) Placebo Participants will receive matching SC injection of placebo on Day 1. Part 2 Placebo MAD (Global) Placebo Participants will receive matching SC injection of placebo on Days 1 and 15. Part 2 Cohort 3 MAD (Chinese Participants) AZD1163 Participants will receive SC injection of AZD1163 on Days 1 and 15. Part 2 Placebo MAD (Chinese participants) Placebo Participants will receive matching SC injection of placebo on Days 1 and 15. Part 2 Placebo MAD (Japanese participants) Placebo Participants will receive matching SC injection of placebo on Days 1 and 15. Part 1 Cohort 4 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 2 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 5a SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 5b SAD AZD1163 Participants will receive SC injection of AZD1163 on Day 1. Part 1 Cohort 6 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 7 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 8 SAD AZD1163 Participants will receive IV infusion of AZD1163 on Day 1. Part 1 Cohort 9 SAD (Chinese Participants) AZD1163 Participants will receive SC injection of AZD1163 on Day 1. Part 2 Cohort 1 MAD (Global) AZD1163 Participants will receive SC injection of AZD1163 on Days 1 and 15. Part 2 Cohort 2 MAD (Global) AZD1163 Participants will receive SC injection of AZD1163 on Days 1 and 15. Part 2 Cohort 4 MAD (Japanese participants) AZD1163 Participants will receive SC injection of AZD1163 on Days 1 and 15.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) From Day -1 until end of study (Day 450) To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.
- Secondary Outcome Measures
Name Time Method Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf) Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450 To characterize the pharmacokinetics (PK) of AZD1163 following IV/SC administration of single and multiple ascending doses.
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450 To characterize the PK of AZD1163 following IV/SC administration of single and multiple ascending doses.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450 To characterize the PK of AZD1163 following SC administration of single and multiple ascending doses.
Volume of distribution (apparent) at steady state following extravascular administration (Vz/F) Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450 To characterize the PK of AZD1163 following SC administration of single and multiple ascending doses.
Maximum observed plasma (peak) drug concentration (Cmax) Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450 To characterize the PK of AZD1163 following IV/SC administration of single and multiple ascending doses.
Number of participants with positive anti-AZD1163 antibodies Part 1: Day 1, 11, 29, 113, 225, 281, 365, 450; Part 2: Day 1, 15, 29, 57, 113, 281, 365, 450 To evaluate the immunogenicity of AZD1163.
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany