Safety and tolerability of 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
This study is testing a new drug called AZD1163 to see if it's safe and tolerable for healthy volunteers when given through an IV or injection.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 4 sites (Glendale, California and 3 other locations) |
| Trial ID | NCT06103877 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy male and female volunteers aged 18-55 with a BMI between 18 and 32 kg/m².
Not a fit: Patients with significant medical histories or current diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety data for AZD1163, paving the way for its use in treating conditions like rheumatoid arthritis.
How similar studies have performed: Previous studies have shown success in evaluating the safety and tolerability of new compounds in healthy volunteers, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Glendale, California and 3 other locations
- Research Site — Glendale, California, United States (Recruiting)
- Research Site — Brooklyn, Maryland, United States (Recruiting)
- Research Site — Berlin, Germany (Terminated)
- Research Site — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.