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NCT06103877 | RECRUITING | Healthy Volunteers

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

AstraZeneca

Brief Summary:

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

Condition or disease

Healthy Volunteers

Intervention/treatment

AZD1163

Placebo

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 99 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-11-01
Estimated Primary Completion Date : 2025-04-03
Estimated Study Completion Date : 2026-04-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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 an approved method of highly effective 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
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers

Location Details

NCT06103877

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How to Participate

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Locations

RECRUITING

United States, California

Research Site

Glendale, California, United States, 91206

RECRUITING

United States, Maryland

Research Site

Brooklyn, Maryland, United States, 21225

RECRUITING

Germany,

Research Site

Berlin, Germany, 14050