A first-in-human study of APG333 in healthy participants

Exclusion Criteria8

• Evidence of clinically significant abnormalities or disease. History of any of the following:
• a. Clinically significant opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia) within 5 years prior to Screening
• b. Serious local infection (eg, cellulitis) or system infection (eg, septicemia) within 3 months prior to Screening
• Known history of illicit drug abuse, harmful alcohol use (defined as an average of >10 standard drinks per week or at the Investigator’s discretion) or alcoholism, and/or excessive tobacco use (defined as >=5 cigarettes or e-cigarette equivalent [0.5 mL e cigarette fluid equivalent to 5 cigarettes] per day) within 2 years prior to Screening; positive screen for drugs of abuse (except tetrahydrocannabinol [THC]), or positive alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking and vaping for the duration of their stay in the CRU. Participants may be rescreened for drugs of abuse or alcohol breath test at the Investigator’s discretion
• History of severe allergic reactions or hypersensitivity (ie, anaphylaxis)
• If female, nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of study drug administration
• Use of any prescription or nonprescription medication 7 days prior to dosing through CRU discharge Day 4 (exception: contraceptives, hormone replacement therapy, vitamins, over-the-counter [OTC] antihistamines, OTC topical steroids, or acetaminophen/paracetamol up to 2 gram (g) per day prior to dosing is permitted)
• Use of any investigational drug therapy within 30 days or 5 half-lives (whichever is longer) prior to study drug dosing through 5 half-lives after the last dose of study drug