COMPLETED

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

Conditions

Healthy Volunteers Rheumatoid arthritis Pharmocokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-11-01

Study Completion:2026-01-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06103877

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.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Research Site

Glendale, California, 91206

United States

Research Site

Brooklyn, Maryland, 21225

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2026-01-13

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2026-01-13

Terms related to this study

Keywords Provided by Researchers

Rheumatoid arthritis
Pharmocokinetics
Healthy volunteers

Additional Relevant MeSH Terms

Healthy Volunteers