The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
All females must have negative pregnancy test and females of childbearing potential must not be lactating and must agree to use an approved method of highly effective contraception.
Have a Body Mass Index between 18 and 30 kg/m2 inclusive and weigh at least 45 kg at Screening.
Part 2, Japanese participants only: Japanese participants must have been born in Japan, have 2 Japanese biological parents and 4 Japanese grandparents (as confirmed by the interview), and must not have lived outside of Japan for more than 10 years at the time of the Screening Visit.
History of any clinically important disease or disorder which, in the opinion of the Principal Investigator, 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 chest irradiation, fibrosis, malignancy, surgical procedure, trauma or liver disease.
Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
Sequential
AZD4916
DrugAZD4916 will be administered as oral solution.
Placebo
Other interventionPlacebo will be administered as oral solution.
Number of participants with adverse events (AEs)
The safety and tolerability of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses to healthy participants (including Japanese and Chinese) will be assessed.
Area under concentration-time curve from time zero to infinity (AUCinf)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Area under concentration-time curve in the dosing interval (AUCtau)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Maximum observed drug concentration (Cmax)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
Parexel
Collaborator
