A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants
- Conditions
- Healthy Participants Study
- Registration Number
- NCT06311760
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria:<br><br> - All females must have a negative pregnancy test at screening and on admission to the<br> Clinical Unit.<br><br> - Females of childbearing potential must not be lactating and if heterosexually<br> active, must agree to use an approved method of highly effective contraception.<br><br> - Have a body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m^2)<br> inclusive and weigh at least 50 kilograms (kg) at screening.<br><br>Exclusion Criteria:<br><br> - History of any clinically important disease or disorder which, in the opinion of the<br> principal investigator (PI), may either put the participant at risk because of<br> participation in the study, or influence the results or the participant's ability to<br> participate in the study.<br><br> - History or presence of gastrointestinal, hepatic, or renal disease, or any other<br> condition known to interfere with absorption, distribution, metabolism, or excretion<br> of drugs.<br><br> - Current smokers or those who have smoked or used nicotine products (including<br> e-cigarettes) within the previous 6 months prior to screening as well as individuals<br> with a smoking history of tobacco greater than 5 pack years.<br><br> - History of alcohol or drug abuse within the past 2 years that, according to the PI,<br> might affect assessments of safety or ability of participant to comply with all<br> study requirements.<br><br> - Any drug therapy within 7 days prior to Day 1 (except contraceptives, HRT, or a<br> single use of acetaminophen, aspirin, antihistamine, or combination OTC product that<br> contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory<br> agent at a dose equal to or lower than that recommended on the package). Vitamins<br> and other nutritional supplements that are not newly introduced, that is, have been<br> taken for at least 30 days prior to enrollment, are not exclusionary.<br><br> - Positive screen for drugs of abuse, alcohol, or cotinine at screening or on<br> admission to the Clinical Unit.<br><br> - Any abnormalities in clinical chemistry, hematology, coagulation, or urinalysis<br> results.<br><br> - History of severe allergy/hypersensitivity or ongoing clinically important<br> allergy/hypersensitivity.<br><br> - Receipt of another new chemical entity (defined as a compound which has not been<br> approved for marketing) within 30 days or 5 half-lives (whichever is longer) of the<br> study intervention administration in this study. The period of exclusion begins one<br> month after the final dose.<br><br> - Receipt of any vaccine within 7 days prior to study intervention administration or<br> planned receipt within 28 days after study intervention administration.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events;Number of Participants with Adverse Events of Special Interest (AESI)
- Secondary Outcome Measures
Name Time Method Maximum Observed Drug Concentration (Cmax);Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast);Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity);Number of Participants with Positive Anti-drug Antibodies (ADAs)