Healthy Participants
Conditions
Keywords
Monoclonal antibody
Brief summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study in healthy Japanese participants to investigate 2 dose levels of AZD0292. Participants will be randomized to receive either AZD0292 or placebo, proceeding with sentinel cohorts. The study will comprise: * A Screening Period of maximum 28 days. * A Treatment Period during which participants will be resident at the site from the day before study intervention administration (Day -1) until at least 24 h post-EOI with study intervention; and discharged on Day 2. * A Follow-up Period from Day 3 to Day 16. * An extended Follow-up Period from Day 17 to Day 161.
Interventions
DRUGAZD0292
Single dose of AZD0292 will be administered as an IV infusion.
DRUGPlacebo
Single dose of placebo will be administered as an IV infusion.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese participants with suitable veins for cannulation or repeated venipuncture. * Women of childbearing potential (WOCBP) must have a negative pregnancy test and must not be lactating. * Participants must agree to use an approved method of highly effective contraception as defined in the protocol. * Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 45 kg at screening.
Exclusion criteria
* History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. * History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * History of malignancy, other than treated non-melanoma skin cancers or locally-treated cervical cancer, in the previous 5 years. * Any clinically important illness, chronic infections or individuals who are at increased risk of infection. * History of acquired or inherited immunodeficiency disorders. * History of severe coronavirus disease 2019 (COVID-19) infection requiring hospitalization within the last 12 months or clinical history compatible with ongoing long COVID-19. * Current smokers or those who have smoked or used nicotine products within the previous 6 months prior to screening. * History of alcohol or drug abuse within the past 2 years. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0292 and excipients contained in AZD0292. * Known hypersensitivity to antihistamines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI) | Up to Extended Follow-up Period (Day 161) | To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed drug concentration (Cmax) | From Day 1 to Extended Follow-up Period (Day 161) | To characterize the Cmax of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants. |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | From Day 1 to Extended Follow-up Period (Day 161) | To characterize the AUClast of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants. |
| Area under concentration-time curve from time 0 to infinity (AUCinf) | From Day 1 to Extended Follow-up Period (Day 161) | To characterize the AUCinf of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants. |
| Number of participants with positive anti-drug antibodies (ADAs) to AZD0292 in serum | From Day 1 to Extended Follow-up Period (Day 161) | To evaluate the ADA responses following administration of single ascending doses of AZD0292 to healthy Japanese adult participants. |
Countries
Japan
Outcome results
None listed