NCT06103877CompletedPhase 1
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
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
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 23 Oct 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 13 Jan 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06103877
- EU CT number
- 2023-509574-34-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 108
- From 1 Nov 2023 to the primary completion date, 13 Jan 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received another new chemical entity
- 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
Other illness
- 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
- History of latent or active tuberculosis (TB) or exposure to endemic areas
- 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
Lab values
- 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)
Other
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening
- Evidence of active TB or untreated/inadequately/inappropriately treated for latent TB
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parexel International GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| - Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.