Trial · NCT07901595
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
NCT07901595, Phase 1, Phase 2, Not yet recruiting, Paulex Bio Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes. Trials, record NCT07901595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901595
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
- NCT number
- NCT07901595
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 147 participants, estimated
- Lead sponsor
- Paulex Bio Inc.
- Conditions
- Healthy Volunteers and Diabetes Participants
- Interventions
- PAL-119, Placebo
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1 Part 1: Safety and tolerability of PAL-119 in healthy volunteers | 8 days | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 1 Part 2: Safety and tolerability of PAL-119 in healthy volunteers | 17 days | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 1 Part 3: Safety and tolerability of PAL-119 in healthy volunteers | 8 days | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 2 Part 4: Safety and tolerability of PAL-119 in adult participants with Type 2 diabetes | 17 weeks | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 2 Part 4: Incidence and severity of hypoglycemic episodes in adult participants with Type 2 diabetes | 17 weeks | hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors |
| Primary | Phase 2 Part 5: Safety and tolerability of PAL-119 in adult participants with Type 1 diabetes | 17 weeks | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 2 Part 5: Incidence and severity of hypoglycemic episodes in adult participants with Type 1 diabetes | 17 weeks | hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors |
| Primary | Phase 2 Part 5: Incidence and severity of diabetic ketoacidosis and episodes of hyperglycemia with ketonemia not meeting diagnostic criteria for diabetic ketoacidosis in adult participants with Type 1 diabetes | 17 weeks | Incidence of clinically diagnosed diabetic ketoacidosis during the defined time frame of study. Diabetic ketoacidosis (DKA) is a serious, life-threatening emergency that happens when your body lacks enough insulin to turn blood sugar into energy, forcing it to break down fat into toxic acids called ketones. |
| Secondary | Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-T 1/2 | 8 days | T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Secondary | Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-AUC | 8 days | The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 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/NCT07901595
GET https://conductscience.org/api/trials/v1/NCT07901595/registered?page=2