A First-in-human Study of APG808 in Healthy Participants and in Patients With Mild-to-moderate Asthma

Exclusion Criteria20

• Willing to use a highly effective method of contraception from admission through 30 days after EOS or 5 half-lives after the last administration of study drug, whichever is longer
• Willing to abstain from regular, continuous alcohol use (defined as an average of >10 standard drinks per week or at the Investigator's discretion) or tobacco use (defined as >=5 cigarettes per day or equivalent) for 48 hours prior to admission to the CRU (Day -1) and any illicit drugs of abuse for >=48 hours prior to admission to the CRU (Day -1)
• For SAD cohorts-
• Evidence of clinically significant abnormalities or disease
• 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 per day or equivalent) within 2 years prior to Screening (or at the Investigator’s discretion); positive screen for drugs of abuse (except tetrahydrocannabinol), or positive cotinine or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking 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 (i.e., anaphylaxis)
• If female, nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of last study drug administration
• 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
• For MD cohort-
• Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of screening; any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to screening
• Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia
• History of biologics use for treatment or control of asthma
• Any concomitant respiratory disease that in the opinion of the Investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of patient safety or study results
• Respiratory Infection
• Evidence of clinically significant abnormalities or disease other than as previously described
• Current smokers or patients with a smoking history of >=10 pack years (number of pack years = number of cigarettes per day/20*number of years smoked). Former smokers with <10 pack years must have stopped for at least 12 months to be eligible for 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; positive screen for drugs of abuse (except tetrahydrocannabinol), or positive cotinine or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion). Patients 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 last study drug administration
• 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