A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
NCT ID: NCT06103877
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
108 participants
INTERVENTIONAL
2023-11-01
2026-01-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part 1 Cohort 1 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 2 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 3 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 4 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 5a SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 5b SAD
Participants will receive SC injection of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 6 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 7 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Cohort 8 SAD
Participants will receive IV infusion of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Pooled Placebo SAD IV
Participants will receive matching IV infusion of placebo on Day 1.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Part 1 Placebo SAD SC
Participants will receive matching SC injection of placebo on Day 1.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Part 1 Cohort 9 SAD (Chinese Participants)
Participants will receive SC injection of AZD1163 on Day 1.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 1 Placebo SAD (Chinese Participants)
Participants will receive matching SC injection of placebo on Day 1.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Part 2 Cohort 1 MAD (Global)
Participants will receive SC injection of AZD1163 on Days 1 and 15.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 2 Cohort 2 MAD (Global)
Participants will receive SC injection of AZD1163 on Days 1 and 15.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 2 Placebo MAD (Global)
Participants will receive matching SC injection of placebo on Days 1 and 15.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Part 2 Cohort 3 MAD (Chinese Participants)
Participants will receive SC injection of AZD1163 on Days 1 and 15.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 2 Cohort 4 MAD (Japanese participants)
Participants will receive SC injection of AZD1163 on Days 1 and 15.
AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Part 2 Placebo MAD (Chinese participants)
Participants will receive matching SC injection of placebo on Days 1 and 15.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Part 2 Placebo MAD (Japanese participants)
Participants will receive matching SC injection of placebo on Days 1 and 15.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Interventions
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AZD1163
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1.
In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
Placebo
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1.
In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Glendale, California, United States
Research Site
Brooklyn, Maryland, United States
Research Site
Berlin, , Germany
Countries
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Other Identifiers
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D9640C00001
Identifier Type: -
Identifier Source: org_study_id
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