Trial · NCT07889505
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 54
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part B: Change from Baseline in 4-Hour Mixed-Meal Tolerance Test (MMTT)-Stimulated C-Peptide Area Under the Curve (AUC) | Part B: Approximately 4 months. | 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). |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | AUC\_Area under the serum concentration-time profile |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | Cmax\_The peak post-dose concentration |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | Tmax\_Time at which Cmax is observed |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | T1/2\_Terminal phase elimination half-life |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | MRT\_Mean Residence Time |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | CL/F\_Apparent Clearance |
| Primary | Part A: Pharmacokinetics (PK) of PS1 | Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8. | Vd/F\_Apparent volume of distribution |
| Secondary | 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) | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | All adverse events (AEs) will be assessed for severity by the investigator based on NCI-CTCAE v5.0 |
| Secondary | Part A & Part B: Abnormalities in Physical examination | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Participants with abnormal Physical examination findings |
| Secondary | Part A & Part B: Abnormalities in 12-lead electrocardiogram (ECG) results | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | 12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval will be recorded. \[Unit: msec\]) |
| Secondary | Part A & Part B: Abnormalities in 12-lead electrocardiogram (ECG) results | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | 12-lead electrocardiogram (EKG) (Ventricular rate will be recorded. \[Unit: beats/min\]) |
| Secondary | Part A & Part B: Abnormalities in vital signs | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Vital signs (Systolic Blood Pressure \& Diastolic Blood Pressure)(Unit: mmHg) |
| Secondary | Part A & Part B: Abnormalities in vital signs | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Vital signs (Pulse rate) (Unit: beats/min) |
| Secondary | Part A & Part B: Abnormalities in vital signs | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Vital signs (Respiratory Rate) (Unit: breaths/min) |
| Secondary | Part A & Part B: Abnormalities in vital signs | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Vital signs (Temperature) (Unit: Celsius) |
| Secondary | Part A & Part B: Abnormalities in clinical laboratory examination | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Participants with abnormal laboratory - Hematology physiological parameter tests results (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) (Unit: g/dL) |
| Secondary | Part B: Pharmacokinetics (PK) of PS1 | Part B: Approximately 5 months. | Vd/F\_Apparent volume of distribution |
| Secondary | Part A & Part B: Abnormalities in clinical laboratory examination | Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months. | Participants with abnormal laboratory - Hematology physiological parameter tests results (hematocrit, HbA1c and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) (Unit: %) |
| Secondary | Part B: Pharmacokinetics (PK) of PS1 | Part B: Approximately 5 months. | CL/F\_Apparent Clearance |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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