A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
Key facts
- Study ID
- NCT06103877
- Run by
- AstraZeneca
- People needed
- 108
- Starts
- 2023-11-01
- Expected to finish
- 2026-01-13
- Last updated by the study team
- 2026-01-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Research Site — Glendale, California, United States
- Research Site — Brooklyn, Maryland, United States
- Research Site — Berlin, Germany
Full record on ClinicalTrials.gov
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