Status:
ACTIVE_NOT_RECRUITING
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
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 D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06103877
Start Date
November 1 2023
End Date
January 13 2026
Last Update
January 8 2026
Active Locations (3)
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1
Research Site
Glendale, California, United States, 91206
2
Research Site
Brooklyn, Maryland, United States, 21225
3
Research Site
Berlin, Germany, 14050