Trial · NCT07889505
A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes
NCT07889505, Phase 2, Not yet recruiting, Pharmasaga Co. Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes. Trials, record NCT07889505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07889505
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes
- NCT number
- NCT07889505
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Pharmasaga Co. Ltd.
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- PS1, Placebo
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07889505
GET https://conductscience.org/api/trials/v1/NCT07889505/registered?page=2