Healthy Participants Study
Conditions
Keywords
Monoclonal antibody
Brief summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.
Detailed description
This is a First-time-in-human (FTiH) trial. Eligible participants will be randomized to receive AZD0292 or Placebo. Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention. The study will comprise: 1. A Screening Period of maximum 28 days. 2. A Treatment Period 3. A Follow-up Period from Day 3 to Day 16 4. An extended Follow-up Period from Day 17 to Day 61 Participants will be involved in this study for a maximum duration of 13 weeks.
Interventions
DRUGAZD0292
AZD0292 will be administered as single dose via IV infusion.
DRUGPlacebo
Placebo will be administered as IV infusion.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* All females must have a negative pregnancy test at screening and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception. * Have a body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m\^2) inclusive and weigh at least 50 kilograms (kg) at screening.
Exclusion criteria
* History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), 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. * Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 6 months prior to screening as well as individuals with a smoking history of tobacco greater than 5 pack years. * History of alcohol or drug abuse within the past 2 years that, according to the PI, might affect assessments of safety or ability of participant to comply with all study requirements. * Any drug therapy within 7 days prior to Day 1 (except contraceptives, HRT, or a single use of acetaminophen, aspirin, antihistamine, or combination OTC product that contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, that is, have been taken for at least 30 days prior to enrollment, are not exclusionary. * Positive screen for drugs of abuse, alcohol, or cotinine at screening or on admission to the Clinical Unit. * Any abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longer) of the study intervention administration in this study. The period of exclusion begins one month after the final dose. * Receipt of any vaccine within 7 days prior to study intervention administration or planned receipt within 28 days after study intervention administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | Up to 13 weeks | The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed. |
| Number of Participants with Adverse Events of Special Interest (AESI) | Up to 13 weeks | The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) | From Dosing (Day 1) to end of the study (up to 13 weeks) | The PK (Cmax) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed. |
| Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast) | From Dosing (Day 1) to end of the study (up to 13 weeks) | The PK (AUClast) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed. |
| Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity) | From Dosing (Day 1) to end of the study (up to 13 weeks) | The PK (AUCinfinity) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed. |
| Number of Participants with Positive Anti-drug Antibodies (ADAs) | From Dosing (Day 1) to end of the study (up to 13 weeks) | The ADA responses following IV administration of single ascending doses of AZD0292 to healthy adult participants will be evaluated. |
Countries
United States
Outcome results
None listed