A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Biological: AZD1163

Study type: Interventional

Funder types: Industry

Identifiers

NCT06103877

D9640C00001

Details and patient eligibility

About

A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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108 participants in 20 patient groups, including a placebo group

Part 1 Cohort 1 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 2 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 3 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 4 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 5a SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 5b SAD

Active Comparator group

Description:

Participants will receive SC injection of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 6 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 7 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Cohort 8 SAD

Active Comparator group

Description:

Participants will receive IV infusion of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Pooled Placebo SAD IV

Placebo Comparator group

Description:

Participants will receive matching IV infusion of placebo on Day 1.

Treatment:

Other: Placebo

Part 1 Placebo SAD SC

Placebo Comparator group

Description:

Participants will receive matching SC injection of placebo on Day 1.

Treatment:

Other: Placebo

Part 1 Cohort 9 SAD (Chinese Participants)

Active Comparator group

Description:

Participants will receive SC injection of AZD1163 on Day 1.

Treatment:

Biological: AZD1163

Part 1 Placebo SAD (Chinese Participants)

Placebo Comparator group

Description:

Participants will receive matching SC injection of placebo on Day 1.

Treatment:

Other: Placebo

Part 2 Cohort 1 MAD (Global)

Active Comparator group

Description:

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Treatment:

Biological: AZD1163

Part 2 Cohort 2 MAD (Global)

Active Comparator group

Description:

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Treatment:

Biological: AZD1163

Part 2 Placebo MAD (Global)

Placebo Comparator group

Description:

Participants will receive matching SC injection of placebo on Days 1 and 15.

Treatment:

Other: Placebo

Part 2 Cohort 3 MAD (Chinese Participants)

Active Comparator group

Description:

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Treatment:

Biological: AZD1163

Part 2 Cohort 4 MAD (Japanese participants)

Active Comparator group

Description:

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Treatment:

Biological: AZD1163

Part 2 Placebo MAD (Chinese participants)

Placebo Comparator group

Description:

Participants will receive matching SC injection of placebo on Days 1 and 15.

Treatment:

Other: Placebo

Part 2 Placebo MAD (Japanese participants)

Placebo Comparator group

Description:

Participants will receive matching SC injection of placebo on Days 1 and 15.

Treatment:

Other: Placebo