The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.
Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis.
All values for hematology, coagulation and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator. Clinical laboratory tests may be repeated once.
Use of any investigational drug or device within 30 days of the first dose of INS1033, or within 5 half-lives, whichever is longer.
Any disease e.g. which, in the opinion of the Investigator, poses an unacceptable risk to the participants.
Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.
Sequential
INS1033
DrugOral solution
Placebo
DrugOral solution
Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
Plasma Concentration of INS1033
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