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

Description

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

Conditions

Healthy Volunteers

Study Overview

Study Details

Study overview

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

A Phase I, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AZD1163 Administered as Single and Multiple Ascending Doses in Healthy Volunteers

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

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Glendale

Research Site, Glendale, California, United States, 91206

Brooklyn

Research Site, Brooklyn, Maryland, United States, 21225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 an approved method of highly effective 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

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-04-27