Clinical Research Directory

Inclusion Criteria: * Part A * Male or female non-Asian participants aged 18 to 60 years, inclusive at screening. * BMI between 18 and 32 kg/m2. * Overtly healthy participant, who is considered to be generally healthy based on medical history, vital signs, laboratory tests, 12 lead ECG, and physical examination, as judged by the investigator. * With HbA1c value of \<6.5% and fasting plasma glucose \<110 mg/dL at screening. * With estimated glomerular filtration rate (eGFR) \>80 mL/min/1.73 m² (according to a chronic kidney disease epidemiology collaboration equation \[CKD-EPI\] 2021 creatinine equation for adults). * Part B * Male or female participants aged 18 to 50 years, inclusive, at the time of signing the informed consent form (ICF). * Participants have received a diagnosis of T1D within ≤12 months according to American Diabetes Association (ADA) criteria at the time of screening. * Documented treatment with stable exogenous insulin therapy for a minimum of 14 consecutive days prior to randomization. * Evidence of residual endogenous β-cell function, defined as a peak stimulated C-peptide of ≥0.2 pmol/mL from a standardized 2-hour MMTT at screening. * Participants have a positive result on testing for at least 1 of the T1D-related autoantibodies before randomization (results from a local laboratory are acceptable). * Participants are able to comply with the SOC of T1D management and all protocol procedures for the duration of the study. * Part A and Part B * Negative test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti-hepatitis C virus (HCV) antibody, and human immunodeficiency virus at screening. Participants with positive anti-HCV may be enrolled only if they have a negative HCV RNA result during the screening period. * Female participants of childbearing potential must have a negative result on a highly sensitive serum (β human chorionic gonadotropin) test at screening. * Participants agree not to receive other forms of experimental treatment during the study, particularly agents that may be immune modulatory in nature and/or stimulate pancreatic β cell regeneration or insulin secretion. Exclusion Criteria: * Part A * History of type I or type II diabetes mellitus. * Participants who are receiving systemic treatment with any prescription or over-the-counter medication that, in the investigator's judgment, may interfere with safety or PK assessments within 7 days before dosing. * Participants who have received a strong CYP enzyme inhibitor or inducer within 14 days before dosing. * Received any vaccination within 2 weeks or live or attenuated vaccines within 4 weeks before screening. * Known hypersensitivity to any of the components of PS1 tablet. * History of pancreatitis. * History of major clinically significant hematologic, renal, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, immune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within 3 months of screening that may significantly alter the biomarker panel, require receiving any systemic medications, or interfere with the interpretation of data, as judged by the investigator. * Serum amylase \>1.5 × ULN or lipase \>1.5 × ULN, at screening. * Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × ULN, or total bilirubin \>1.5 × ULN (except in participants with Gilbert's syndrome), at screening. * Clinically significant ECG abnormality at screening. * Took glucose-lowering medications within the last 2 weeks prior to screening * Received any investigational therapy from another clinical study within the last 12 weeks prior to screening. * Received any systemic steroids (inhaled and intranasal steroids are permitted) or other immunosuppressive medications within 4 weeks prior to dosing. * Underwent any major surgery within 12 weeks or any non-major surgeries within 4 weeks prior to dosing * Part B * Have known allergies, severe reactions, intolerance, hypersensitivity, or anaphylaxis to PS1 or any of its components or its excipients * Have been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical study within 30 days or 5 half lives (whichever is longer) before the first dose of the study drug or have received an investigational treatment with the potential for T1D disease modification * Have an HbA1c ≥10% * Have experienced 1 or more episodes of DKA within 30 days prior to randomization or have had 1 or more emergency room visits or hospitalizations due to poor glucose control (severe hyperglycemia or hypoglycemic episodes) within 1 month prior to randomization. * Have a history of acute or chronic pancreatitis * Have a serum triglyceride level \>500 mg/dL (5.6 mmol/L) at screening * Have a serum lipase or amylase level \>1.5 × ULN at screening * Have eating disorders or any gastrointestinal problems that might, in the opinion of the investigator, impact/confound the results of the study or interfere with the participant's ability to comply with the study procedures. * Have a known malignancy, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma. * Have a diagnosis of sickle cell disease or other hemoglobinopathies that may interfere with interpretation of HbA1c or glycemic endpoints. * Have a diagnosis of significant liver disease at screening, or ALT and/or AST \>2 × or total bilirubin \>1.5 × the age- and sex-specific ULN (Note: Participants with Gilbert's syndrome may be allowed to enroll upon approval by the medical monitor). * Have any of the following hematologic parameters, confirmed by repeat tests, within 10 days before randomization or the first dose of the study drug: * Lymphocyte count: \<500/μL * Neutrophil count: \<1500/μL * Platelet count: \<100,000/μL * Hemoglobin: \<10 g/dL * Have impaired renal function, defined by an eGFR (according to CKD-EPI 2021 creatinine equation) of \<60 mL/min/1.73 m2. * Have received current or prior (within 30 days before screening) treatment that is known to cause a significant ongoing change in the course of T1D or immunologic status, including high dose inhaled, extensive topical, or systemic glucocorticoids. (Note: Short courses, ie, approximately 2 weeks or less, of corticosteroids for transient conditions are allowed). * Have current or prior (within 30 days before screening) use of drugs other than insulin to treat hyperglycemia (eg, metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dipeptidyl peptidase-4 inhibitors, or amylin).