Type 1 Diabetes MellitusPhase 2NCT07889505
A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes
A Phase 2 study testing PS1 in people with Type 1 Diabetes Mellitus, run by Pharmasaga Co. Ltd..
Trial summary
This study consists of 2 sub-studies, including Part A and Part B. Part A is intended to further characterize the pharmacokinetic (PK) profile of PS1 based on existing single ascending dose (SAD) and multiple ascending dose (MAD) data, while Part B is designed as an exploratory study to evaluate the potential clinical… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- PS1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2026to 31 Oct 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Two-Part Study of Oral PS1 Comprising a Pharmacokinetic, Safety, and Tolerability Bridging Study in Healthy Volunteers and an Exploratory Efficacy, Safety, Tolerability, and Pharmacokinetic Study in Adults With Newly Diagnosed Type 1 Diabetes
This study consists of 2 sub-studies, including Part A and Part B. Part A is intended to further characterize the pharmacokinetic (PK) profile of PS1 based on existing single ascending dose (SAD) and multiple ascending dose (MAD) data, while Part B is designed as an exploratory study to evaluate the potential clinical effects of PS1 in adults with newly diagnosed type 1 diabetes mellitus (T1DM). PS1 is a potential blood glucose-lowering medication being developed by Pharmasaga Co., Ltd. for the treatment of T1DM.
Read the detailed description
Part A This is an open-label, parallel-group sub-study to characterize the PK characteristics, and determine the safety, and tolerability of PS1 via oral administration in healthy volunteers.
Approximately 12 eligible participants will receive a single dose of PS1 in Part A, with 6 participants receiving 25 mg and 6 participants receiving 50 mg.
Part A will consist of a screening period (Visit 1; Days -28 to -2), predose assessments visit (Visit 2; Day-1), a treatment period (Visit 3; Day 1, Day 2), and a post-treatment observation visit on Day 8 (Visit 4). Participants may be hospitalized overnight, at the discretion of the investigator/site, to facilitate the conduct of scheduled Day -1 and Day 1/Day 2 study procedures and receive single dose of PS1 on Day 1 (Visit 3) and may continue to be hospitalized for PK sample collection till Day 2.
Blood plasma samples will be collected at following timepoints: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing. The participant will be discharged immediately (if hospitalized) after the 24-hour PK sample collection time point on Day 2. On Day 8, the participant will come for post-treatment observation visit and an additional PK sample will be collected on the same day, which will be the end of study (EOS) for participant.
The decision to proceed to Part B will be made after all participants in Part A have completed dosing and the planned safety follow-up period.
Part B This is a randomized, double-blind, placebo-controlled sub-study to evaluate the efficacy, safety, and PK characteristics of PS1 via oral administration in combination with standard of care (SOC) for adults diagnosed with T1D within ≤12 months.
Part B consists of a screening period (Weeks -4 to -1; followed by a predose assessments visit [Visit 2; Day-1]), a treatment period (Weeks 1 to 12), and a post-treatment observation period (Weeks 13 to 16).
During the treatment period, approximately 24 eligible participants will be randomly assigned in a 1:1:1 ratio to either the 50 mg treatment group (PS1 + SOC, N = 8), 25 mg treatment group (PS1 + SOC, N = 8), or control group (placebo + SOC, N = 8). Each participant will receive either PS1 at a dose of 50 mg QD, PS1 at a dose of 25 mg QD, or placebo QD, for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment. All participants will receive SOC for T1D for the entire sub-study period (treatment period + post treatment observation period). Participants may be hospitalized overnight, at the discretion of the investigator/site, to facilitate the conduct of scheduled Day -1 and Day 1/Day 2 study procedures. A participant will receive first dose of study treatment on Day 1 (Visit 3) and may continue to be hospitalized for PK sample collection till Day 2. All participants will receive standard management of their diabetes (SOC) during the entire study period including the treatment period and post-treatment observation period.
The study will be maintained as blinded, and an independent Data Monitoring Committee (DMC) will be established by the sponsor to review accumulating safety data.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- PS1, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS1Drug
PS1 will be provided as a 120 mg tablet with 25 mg active pharmaceutical ingredient.
PlaceboDrug
Placebo will be provided as a 120 mg tablet.
| Study group | Role | What they receive |
|---|---|---|
| Part A - SAD - 25mg | Experimental | An eligible healthy subject will receive a single dose of 25 mg of PS1 on Day 1 and be followed for 7 days. Receives: Drug: PS1 |
| Part A - SAD - 50mg | Experimental | An eligible healthy subject will receive a single dose of 50 mg of PS1 on Day 1 and be followed for 7 days. Receives: Drug: PS1 |
| Part B - 25mg | Experimental | An eligible subject will receive one 25 mg PS1 and one PS1 matching (placebo) tablet once daily for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment. Receives: Drug: PS1; Drug: Placebo |
| Part B - 50mg | Experimental | An eligible subject will receive two 25 mg PS1 tablets once daily for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment. Receives: Drug: PS1 |
| Part B - placebo | Placebo comparator | An eligible subject will receive two PS1-matching (placebo) tablets once daily for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: Change from Baseline in 4-Hour Mixed-Meal Tolerance Test (MMTT)-Stimulated C-Peptide Area Under the Curve (AUC)
To evaluate the effect of PS1 compared with placebo on 4-hour MMTT-stimulated C-peptide AUC from baseline to Week 12 in adults with newly diagnosed type 1 diabetes (T1D) (≤12 months since diagnosis).
Measured: Part B: Approximately 4 months.
Part A: Pharmacokinetics (PK) of PS1
AUC_Area under the serum concentration-time profile
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Part A: Pharmacokinetics (PK) of PS1
Cmax_The peak post-dose concentration
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Part A: Pharmacokinetics (PK) of PS1
Tmax_Time at which Cmax is observed
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Part A: Pharmacokinetics (PK) of PS1
T1/2_Terminal phase elimination half-life
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Part A: Pharmacokinetics (PK) of PS1
MRT_Mean Residence Time
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Part A: Pharmacokinetics (PK) of PS1
CL/F_Apparent Clearance
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Part A: Pharmacokinetics (PK) of PS1
Vd/F_Apparent volume of distribution
Measured: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.
Secondary outcomes (40)
Part A & Part B: Incidence and severity (per Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0) of treatment-emergent adverse events (TEAEs) including hypoglycemia, serious adverse events (SAEs)
All adverse events (AEs) will be assessed for severity by the investigator based on NCI-CTCAE v5.0
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in Physical examination
Participants with abnormal Physical examination findings
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in 12-lead electrocardiogram (ECG) results
12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval will be recorded. [Unit: msec])
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in 12-lead electrocardiogram (ECG) results
12-lead electrocardiogram (EKG) (Ventricular rate will be recorded. [Unit: beats/min])
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in vital signs
Vital signs (Systolic Blood Pressure \& Diastolic Blood Pressure)(Unit: mmHg)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in vital signs
Vital signs (Pulse rate) (Unit: beats/min)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in vital signs
Vital signs (Respiratory Rate) (Unit: breaths/min)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in vital signs
Vital signs (Temperature) (Unit: Celsius)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Hematology physiological parameter tests results (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) (Unit: g/dL)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
Vd/F_Apparent volume of distribution
Measured: Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Hematology physiological parameter tests results (hematocrit, HbA1c and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) (Unit: %)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
CL/F_Apparent Clearance
Measured: Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
MRT_Mean Residence Time
Measured: Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
T1/2_Terminal phase elimination half-life
Measured: Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
Tmax_Time at which Cmax is observed
Measured: Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
Cmax_The peak post-dose concentration
Measured: Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
AUC_Area under the serum concentration-time profile
Measured: Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Hematology physiological parameter tests results (RBC) (Unit: 10^6/uL)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Hematology physiological parameter tests results (platelet and WBC) (Unit: 10^3/uL)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular volume, MCV) (Unit: fL)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular hemoglobin, MCH) (Unit: pg)
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Biochemistry physiological parameter tests results
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part A & Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Urinalysis physiological parameter tests results
Measured: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.
Part B: Pharmacokinetics (PK) of PS1
Rac_Accumulation ratio
Measured: Part B: Approximately 5 months.
Part B: Abnormalities in clinical laboratory examination
Participants with abnormal laboratory - Clinically important hypoglycemic episodes, defined as the total number of episodes of a blood glucose (BG) reading of <54 mg/dL (3.0 mmol/L), episodes of severe cognitive impairment, and/or physical status requiring external assistance for recovery.
Incidence of typical hypoglycemia, defined as BG levels ≥54 mg/dL (3.0 mmol/L) but <70 mg/dL (3.9 mmol/L) and/or non-severe clinical episodes
Measured: Part B: Approximately 4 months.
Part B: Abnormalities in clinical laboratory examination
Participants with incidence of DKA requiring medical attention, defined as a hyperglycemic episode (BG ≥250 mg/dL [13.9 mmol/L]) with serum or urine ketones elevated beyond the upper limit of normal (ULN), along with serum bicarbonate <15 mmol/L, blood pH <7.3, or both, resulting in an outpatient or emergency room visit, or hospitalization
Measured: Part B: Approximately 4 months.
Part B: 4-Hour Mixed-Meal Tolerance Test (MMTT)-Stimulated C-Peptide Area Under the Curve (AUC) at Week 12
The area under the C-peptide concentration-time curve during the 4-hour MMTT, calculated using the protocol-specified method
Measured: Part B: Approximately 4 months.
Part B: To evaluate the effects of PS1 on glycemic control of hemoglobin A1c [HbA1c]
HbA1c level (percentage and mmol/mol)
Measured: Part B: Approximately 4 months.
Part B: To evaluate the effects of PS1 on postprandial metabolic responses
Assessed by glucagon and glucose concentrations and the C-peptide/glucose ratio over 4 hours after the mixed meal tolerance test (MMTT)
Measured: Part B: Approximately 4 months.
Part B: To evaluate the effects of PS1 on key clinical parameters of diabetes management
Exogenous insulin use and insulin dose-adjusted HbA1c (IDAA1c)
Measured: Part B: Approximately 4 months.
Part B: Peak MMTT-Stimulated C-Peptide Concentration at Week 12
The maximum C-peptide concentration measured during the MMTT, based on the protocol-specified sampling time points
Measured: Part B: Approximately 4 months.
Part B: MMTT-Stimulated C-Peptide Concentration at 90 Minutes at Week 12
C-peptide concentration measured 90 minutes after initiation of the MMTT.
Measured: Part B: Approximately 4 months.
Part B: Insulin Dose-Adjusted Peak MMTT-Stimulated C-Peptide Concentration at Week 12
Peak MMTT-stimulated C-peptide concentration adjusted for insulin dose using the protocol-specified calculation method
Measured: Part B: Approximately 4 months.
Part B: Insulin Dose-Adjusted MMTT-Stimulated C-Peptide Concentration at 90 Minutes at Week 12
MMTT-stimulated C-peptide concentration at 90 minutes, adjusted for insulin dose using the protocol-specified calculation method
Measured: Part B: Approximately 4 months.
Part B: Intact Proinsulin-to-C-Peptide Ratio at Week 12
Ratio of intact proinsulin concentration to C-peptide concentration, calculated using the protocol-specified method
Measured: Part B: Approximately 4 months.
Part B: Homeostasis Model Assessment of Beta-Cell Function (HOMA-β) at Week 12
HOMA-β is an estimate of beta-cell function calculated from fasting glucose and fasting insulin concentrations using the protocol-specified formula
Measured: Part B: Approximately 4 months.
Part B: C-Peptide-to-Glucose Ratio at Week 12
Ratio of C-peptide concentration to the corresponding glucose concentration, calculated using the protocol-specified sampling time point and units
Measured: Part B: Approximately 4 months.
Part B: Proinsulin Concentration at Week 12
Proinsulin concentration measured in the specified biological sample using the protocol-specified assay. Specify whether the measure refers to intact proinsulin, total proinsulin, or another defined analyte
Measured: Part B: Approximately 4 months.
Part B: Proinsulin-to-C-Peptide Ratio at Week 12
Ratio of the specified proinsulin concentration to C-peptide concentration, calculated using the protocol-specified method
Measured: Part B: Approximately 4 months.
Part B: C-Peptide-Based Insulinogenic Index at Week 12
An index of glucose-stimulated insulin secretion calculated from C-peptide and glucose measurements using the protocol-specified formula and sampling time points
Measured: Part B: Approximately 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start21 Nov 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A is an open-label, parallel-group sub-study to characterize the PK characteristics, and determine the safety, and tolerability of PS1 via oral administration in healthy volunteers. Part B is a randomized, double-blind, placebo-controlled sub-study to evaluate the efficacy, safety, and PK characteristics of PS1 via oral administration in combination with standard of care (SOC) for adults diagnosed with T1D within ≤12 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmasaga Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889505
- Sponsor's protocol ID
- PS1-I-201
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No