Safety and tolerability of AZD1163 in healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of AZD1163, administered both intravenously and subcutaneously, in healthy participants. It consists of two parts: a Single Ascending Dose (SAD) phase with nine cohorts and a Multiple Ascending Dose (MAD) phase. Participants will undergo a screening period followed by in-clinic observation for each dose, with a total involvement of approximately 70 weeks. The study aims to gather data on the pharmacokinetics of AZD1163 in a controlled environment.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Glendale, California, United States Recruiting
• Research Site
  Brooklyn, Maryland, United States Recruiting
• Research Site
  Berlin, Germany Recruiting
• Research Site
  Berlin, Germany Terminated

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.