Healthy Volunteers and Diabetes ParticipantsPhase 1/2NCT07901595
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
A Phase 1/2 study testing PAL-119 in people with Healthy Volunteers and Diabetes Participants, run by Paulex Bio Inc..
Trial summary
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers and Diabetes Participants
- What is being tested?
- PAL-119
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1 Parts 1, 2 and 3
- Healthy volunteers age 18 to 55 years of age
- Medically healthy with no clinically significant findings
- BMI 18-35 kg/m²
- eGFR ≥90
- Able and willing to provide written informed consent
Show all 26Show fewer
- Able to swallow an oral solid-dosage form of medication.
- Willing and able to follow a low-tyramine diet and abstain from prohibited medications from 48 hours prior to first dose and for the duration of the study and for 14 days after the last dose
- Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- ability to consume high-fat meal (Part 3 only)
- Phase 2 Part 4:
- 18 to ≤70 years of age
- Confirmed Type 2 diabetes diagnosis ≥6 months and ≤15 years prior to screening
- BMI 25 to 40 kg/m² at Screening
- Able and willing to provide written informed consent
- Stable diabetes therapy for ≥12 weeks prior to screening visit
- Willing and able to follow a low-tyramine diet and abstain from prohibited medications for the duration of the study and for 14 days after the last dose
- Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Phase 2 Part 5
- 18 to ≤70 years of age
- Confirmed Type 1 diabetes diagnosis ≥6 months and ≤10 years prior to screening visit
- Stable insulin regimen for ≥12 weeks prior to screening visit
- Willingness to use continuous glucose monitoring (CGM) for continuous periods during the study
- Able and willing to provide written informed consent
- Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Willing and able to follow a low-tyramine diet and abstain from prohibited medications for the duration of the study and for 14 days after the last dose
Who cannot join
- Phase 1 Parts 1, 2 and 3:
- Any physical or psychological condition that prohibits study completion
- Known cardiac disease
- HIV, hepatitis B and/or hepatitis C positive
- Active or history of malignancy
- Blood donation within 30 days
Show all 24Show fewer
- Phase 2 Part 4:
- History of diabetic ketoacidosis or severe hypoglycemia (ADA Level 3) in the 6 months prior to Screening
- Current use of insulin (except ≤20 units/day stable basal insulin for ≥12 weeks
- Any physical or psychological condition that prohibits study completion
- Known cardiac disease
- HIV, hepatitis B and/or hepatitis C positive
- Receipt of investigational products within 30 days
- Phase 2 Part 5:
- History of diabetic ketoacidosis or severe hypoglycemia (ADA Level 3) in the 6 months prior to Screening
- Daily insulin requirement >1.0 units/kg/day
- Any physical or psychological condition that prohibits study completion
- Known cardiac disease
- active autoimmune disease requiring immunosuppression
- diabetic retinopathy
- HIV, hepatitis B and/or hepatitis C positive
- symptomatic neuropathy
- nephrotic-range proteinuria
- Receipt of investigational products within 30 days
About this study
Official title: A Phase 1/2a, First-in-human, Randomized, Blinded, Placebo-controlled, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile and the Effect of Food of Oral PAL-119 in Healthy Volunteers and in Adult Participants With Type 1 or Type 2 Diabetes
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
Read the detailed description
This is a Phase 1/2a, first-in-human, multipart, randomized, study of oral doses of PAL-119 consisting of 2 phases, one in healthy volunteers and one in participants with diabetes.
Phase 1 in healthy volunteers consists of 3 parts:
- Part 1 (SAD): A randomized, blinded, placebo-controlled, single ascending dose (SAD) with up to 6 cohorts
- Part 2 (MAD): A randomized, blinded, placebo-controlled, multiple ascending dose (MAD) with up to 3 cohorts
- Part 3 (Food Effect): A randomized, open-label, 2-sequence, 2-period crossover, single-dose study
Phase 2a in adult participants with diabetes
- Part 4 (T2D): A randomized, double-blinded, placebo-controlled (DBPC), dose ranging, 3-arm study in participants with Type 2 diabetes
- Part 5 (T1D): A randomized, DBPC, 2-arm study in participants with Type 1 diabetes
- Being tested
- PAL-119, Placebo
- Keywords
- Type 1 diabetes, Type 2 diabetes, diabetic ketoacidosis, hypoglycemia, healthy volunteers
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Ketoacidosis, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAL-119Drug
Small synthetic molecule
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Part 1: Active PAL-119 to be administered to healthy volunteers (SAD) | Experimental | Healthy participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered orally once. Randomization to each SAD cohort will be done in a staggered manner Receives: Drug: PAL-119 |
| Phase 1 Part 1: Placebo to be administered to healthy volunteers (SAD) | Placebo comparator | Healthy participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered orally once. Randomization to each SAD cohort will be done in a staggered manner Receives: Drug: Placebo |
| Phase 1 Part 2 Active PAL-119 to be administered to healthy volunteers (MAD) | Experimental | Healthy participants will be randomized in a 3:1 ratio to active PAL-119 or placebo. Participants will receive study intervention over 10 days. Dose regimen TBD Receives: Drug: PAL-119 |
| Phase 1 Part 2: Placebo to be administered to healthy volunteers (MAD) | Placebo comparator | Healthy participants will be randomized in a 3:1 ratio to active PAL-119 or placebo. Participants will receive study intervention over 10 days. Dose regimen TBD Receives: Drug: Placebo |
| Phase 1 Part 3 Active PAL-119 to be administered to healthy volunteers | Experimental | Healthy participants will be randomized 1:1 to receive a single dose of active PAL-119 in either a fasted/fed sequence or a fed/fasted sequence. Receives: Drug: PAL-119 |
| Phase 2 part 4: Active PAL-119 to be administered to participants with Type 2 diabetes | Experimental | Participants with Type 2 Diabetes will be randomized to receive PAL-119 at a 3:3:2 ratio, with participants randomized to receive high dose PAL-119, low dose PAL-119 or placebo for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. Receives: Drug: PAL-119 |
| Phase 2 Part 4: Placebo administered to participants with Type 2 diabetes | Placebo comparator | Participants with Type 2 Diabetes will be randomized to receive PAL-119 at a 3:3:2 ratio, with participants randomized to receive high dose PAL-119, low dose PAL-119 or placebo. Study interventions will be administered for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. Receives: Drug: Placebo |
| Phase 2 Part 5: Active PAL-119 to be administered to participants with Type 1 diabetes | Experimental | Participants with Type 1 Diabetes will be randomized to receive PAL-119 at a 2:1 ratio. Study interventions will be administered for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. Receives: Drug: PAL-119 |
| Phase 2 part 5: Placebo to be administered to participants with Type 1 diabetes | Placebo comparator | Participants with Type 1 Diabetes will be randomized to receive PAL-119 at a 2:1 ratio. Study interventions will be administered for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Part 1: Safety and tolerability of PAL-119 in healthy volunteers
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Measured: 8 days
Phase 1 Part 2: Safety and tolerability of PAL-119 in healthy volunteers
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Measured: 17 days
Phase 1 Part 3: Safety and tolerability of PAL-119 in healthy volunteers
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Measured: 8 days
Phase 2 Part 4: Safety and tolerability of PAL-119 in adult participants with Type 2 diabetes
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Measured: 17 weeks
Phase 2 Part 4: Incidence and severity of hypoglycemic episodes in adult participants with Type 2 diabetes
hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors
Measured: 17 weeks
Phase 2 Part 5: Safety and tolerability of PAL-119 in adult participants with Type 1 diabetes
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Measured: 17 weeks
Phase 2 Part 5: Incidence and severity of hypoglycemic episodes in adult participants with Type 1 diabetes
hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors
Measured: 17 weeks
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
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.
Measured: 17 weeks
Secondary outcomes (24)
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
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%
Measured: 8 days
Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-AUC
The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time.
Measured: 8 days
Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-Tmax
Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin
Measured: 8 days
Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-Cmax
Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose
Measured: 8 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-T 1/2
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%
Measured: 17 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-AUC
The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time
Measured: 17 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-Tmax
Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin
Measured: 17 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-Cmax
Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose
Measured: 17 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: T 1/2
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%
Measured: 8 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: AUC
The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time
Measured: 8 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: Tmax
Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin
Measured: 8 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: Cmax
Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose
Measured: 8 days
Phase 2 Part 4: Change from baseline in serum insulin in adult participants with Type 2 diabetes
Mean change in serum insulin from baseline to end of study. The serum insulin measures the amount of insulin hormone in the blood after a period of fasting to evaluate how well the pancreas produces insulin
Measured: 17 weeks
Phase 2 Part 4: Change from baseline in plasma C-peptide in adult participants with Type 2 diabetes
Mean change in plasma C-peptide levels from baseline to end of study. A plasma C-peptide test measures the level of a byproduct created when the pancreas makes insulin
Measured: 17 weeks
Phase 2 Part 4: Change from baseline in active GLP-1 in adult participants with Type 2 diabetes
Mean change in active GLP-1 (the biologically active, intact forms of the hormone in plasma) from baseline to end of study
Measured: 17 weeks
Phase 2 Part 4: Change from baseline in total GLP-1 in adult participants with Type 2 diabetes
Mean change in total GLP-1(the active and inactive forms of the peptide in serum) from baseline to end of study.
Measured: 17 weeks
Phase 2 Part 4: Change from baseline in Fasting Plasma Glucose in adult participants with Type 2 diabetes
Mean change in fasting blood sugar (serum levels of glucose in mg/dL after 6-8 hours of fasting) from baseline to end of study
Measured: 17 weeks
Phase 2 Part 4: To characterize the PK profile of oral PAL-119 in participants with Type 2 diabetes-trough at steady state
A steady-state trough level is the lowest concentration of a medication in a patient's bloodstream, measured right before the next scheduled dose, after the body has reached a stable balance where drug intake equals elimination
Measured: 17 weeks
Phase 2 Part 5: Change from baseline in serum insulin in adult participants with Type 1 diabetes
Mean change in serum insulin from baseline to end of study. The serum insulin measures the amount of insulin hormone in your blood after a period of fasting to evaluate how well your pancreas produces insulin
Measured: 17 weeks
Phase 2 Part 5: Change from baseline in fasting plasma glucose in adult participants with Type 1 diabetes
Mean change in fasting blood sugar ( serum levels of glucose in mg/dL after 6-8 hours of fasting) from baseline to end of study
Measured: 17 weeks
Phase 2 Part 5: Change from baseline in active GLP-1 in adult participants with Type 1 diabetes
Mean change in active GLP-1 (the biologically active, intact forms of the hormone in plasma) from baseline to end of study
Measured: 17 weeks
Phase 2 Part 5: Change from baseline in total GLP-1 in adult participants with Type 1 diabetes
Mean change in total GLP-1 (the active and inactive forms of the peptide in serum) from baseline to end of study
Measured: 17 weeks
Phase 2 Part 5: Change from baseline in plasma C-peptide in adult participants with Type 1 diabetes
Mean change in plasma C-peptide levels from baseline to end of study. A plasma C-peptide test measures the level of a byproduct created when the pancreas makes insulin
Measured: 17 weeks
Phase 2 Part 5: To characterize the PK profile of oral PAL-119 in participants with Type 1 diabetes-trough at steady state
A steady-state trough level is the lowest concentration of a medication in a patient's bloodstream, measured right before the next scheduled dose, after the body has reached a stable balance where drug intake equals elimination
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers and Diabetes ParticipantsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 Part 3 is open-label 2-sequence, 2-period crossover study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paulex Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901595
- Sponsor's protocol ID
- PAL-119-001
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, First-in-human, Randomized, Blinded, Placebo-controlled, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile and the Effect of Food of Oral PAL-119 in Healthy Volunteers and in Adult Participants With Type 1 or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07901595
- Acronym / sponsor ID
- PAL-119-001
- Keywords
- Type 1 diabetes, Type 2 diabetes, diabetic ketoacidosis, hypoglycemia, healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Paulex Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
Detailed description
This is a Phase 1/2a, first-in-human, multipart, randomized, study of oral doses of PAL-119 consisting of 2 phases, one in healthy volunteers and one in participants with diabetes.
Phase 1 in healthy volunteers consists of 3 parts:
- Part 1 (SAD): A randomized, blinded, placebo-controlled, single ascending dose (SAD) with up to 6 cohorts
- Part 2 (MAD): A randomized, blinded, placebo-controlled, multiple ascending dose (MAD) with up to 3 cohorts
- Part 3 (Food Effect): A randomized, open-label, 2-sequence, 2-period crossover, single-dose study
Phase 2a in adult participants with diabetes
- Part 4 (T2D): A randomized, double-blinded, placebo-controlled (DBPC), dose ranging, 3-arm study in participants with Type 2 diabetes
- Part 5 (T1D): A randomized, DBPC, 2-arm study in participants with Type 1 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Phase 1 Part 3 is open-label 2-sequence, 2-period crossover study.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Part 1: Active PAL-119 to be administered to healthy volunteers (SAD) | Experimental | Drug: PAL-119Healthy participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered orally once. Randomization to each SAD cohort will be done in a staggered manner |
| Phase 1 Part 1: Placebo to be administered to healthy volunteers (SAD) | Placebo comparator | Drug: PlaceboHealthy participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered orally once. Randomization to each SAD cohort will be done in a staggered manner |
| Phase 1 Part 2 Active PAL-119 to be administered to healthy volunteers (MAD) | Experimental | Drug: PAL-119Healthy participants will be randomized in a 3:1 ratio to active PAL-119 or placebo. Participants will receive study intervention over 10 days. Dose regimen TBD |
| Phase 1 Part 2: Placebo to be administered to healthy volunteers (MAD) | Placebo comparator | Drug: PlaceboHealthy participants will be randomized in a 3:1 ratio to active PAL-119 or placebo. Participants will receive study intervention over 10 days. Dose regimen TBD |
| Phase 1 Part 3 Active PAL-119 to be administered to healthy volunteers | Experimental | Drug: PAL-119Healthy participants will be randomized 1:1 to receive a single dose of active PAL-119 in either a fasted/fed sequence or a fed/fasted sequence. |
| Phase 2 part 4: Active PAL-119 to be administered to participants with Type 2 diabetes | Experimental | Drug: PAL-119Participants with Type 2 Diabetes will be randomized to receive PAL-119 at a 3:3:2 ratio, with participants randomized to receive high dose PAL-119, low dose PAL-119 or placebo for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. |
| Phase 2 Part 4: Placebo administered to participants with Type 2 diabetes | Placebo comparator | Drug: PlaceboParticipants with Type 2 Diabetes will be randomized to receive PAL-119 at a 3:3:2 ratio, with participants randomized to receive high dose PAL-119, low dose PAL-119 or placebo. Study interventions will be administered for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. |
| Phase 2 Part 5: Active PAL-119 to be administered to participants with Type 1 diabetes | Experimental | Drug: PAL-119Participants with Type 1 Diabetes will be randomized to receive PAL-119 at a 2:1 ratio. Study interventions will be administered for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. |
| Phase 2 part 5: Placebo to be administered to participants with Type 1 diabetes | Placebo comparator | Drug: PlaceboParticipants with Type 1 Diabetes will be randomized to receive PAL-119 at a 2:1 ratio. Study interventions will be administered for 91 days. Dose regimen TBD. A follow-up safety visit will be conducted 4 weeks after last dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Phase 1 Parts 1, 2 and 3
- Healthy volunteers age 18 to 55 years of age
- Medically healthy with no clinically significant findings
- BMI 18-35 kg/m²
- eGFR ≥90
Key exclusion criteria (24 listed)
- Any physical or psychological condition that prohibits study completion
- Known cardiac disease
- HIV, hepatitis B and/or hepatitis C positive
- Active or history of malignancy
- Blood donation within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAL-119Small synthetic molecule | Drug | Phase 1 Part 1: Active PAL-119 to be administered to healthy volunteers (SAD), Phase 1 Part 2 Active PAL-119 to be administered to healthy volunteers (MAD), Phase 1 Part 3 Active PAL-119 to be administered to healthy volunteers, Phase 2 Part 5: Active PAL-119 to be administered to participants with Type 1 diabetes, Phase 2 part 4: Active PAL-119 to be administered to participants with Type 2 diabetes |
| PlaceboPlacebo | Drug | Phase 1 Part 1: Placebo to be administered to healthy volunteers (SAD), Phase 1 Part 2: Placebo to be administered to healthy volunteers (MAD), Phase 2 Part 4: Placebo administered to participants with Type 2 diabetes, Phase 2 part 5: Placebo to be administered to participants with Type 1 diabetes |
Primary outcome
Phase 1 Part 1: Safety and tolerability of PAL-119 in healthy volunteers
Time frame: 8 days
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Phase 1 Part 2: Safety and tolerability of PAL-119 in healthy volunteers
Time frame: 17 days
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Phase 1 Part 3: Safety and tolerability of PAL-119 in healthy volunteers
Time frame: 8 days
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Phase 2 Part 4: Safety and tolerability of PAL-119 in adult participants with Type 2 diabetes
Time frame: 17 weeks
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Phase 2 Part 4: Incidence and severity of hypoglycemic episodes in adult participants with Type 2 diabetes
Time frame: 17 weeks
hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors
Phase 2 Part 5: Safety and tolerability of PAL-119 in adult participants with Type 1 diabetes
Time frame: 17 weeks
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Phase 2 Part 5: Incidence and severity of hypoglycemic episodes in adult participants with Type 1 diabetes
Time frame: 17 weeks
hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors
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
Time frame: 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.
24 secondary outcomes
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
Time frame: 8 days
Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-AUC
Time frame: 8 days
Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-Tmax
Time frame: 8 days
Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-Cmax
Time frame: 8 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-T 1/2
Time frame: 17 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-AUC
Time frame: 17 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-Tmax
Time frame: 17 days
Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-Cmax
Time frame: 17 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: T 1/2
Time frame: 8 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: AUC
Time frame: 8 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: Tmax
Time frame: 8 days
Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: Cmax
Time frame: 8 days
Phase 2 Part 4: Change from baseline in serum insulin in adult participants with Type 2 diabetes
Time frame: 17 weeks
Phase 2 Part 4: Change from baseline in plasma C-peptide in adult participants with Type 2 diabetes
Time frame: 17 weeks
Phase 2 Part 4: Change from baseline in active GLP-1 in adult participants with Type 2 diabetes
Time frame: 17 weeks
Phase 2 Part 4: Change from baseline in total GLP-1 in adult participants with Type 2 diabetes
Time frame: 17 weeks
Phase 2 Part 4: Change from baseline in Fasting Plasma Glucose in adult participants with Type 2 diabetes
Time frame: 17 weeks
Phase 2 Part 4: To characterize the PK profile of oral PAL-119 in participants with Type 2 diabetes-trough at steady state
Time frame: 17 weeks
Phase 2 Part 5: Change from baseline in serum insulin in adult participants with Type 1 diabetes
Time frame: 17 weeks
Phase 2 Part 5: Change from baseline in fasting plasma glucose in adult participants with Type 1 diabetes
Time frame: 17 weeks
Phase 2 Part 5: Change from baseline in active GLP-1 in adult participants with Type 1 diabetes
Time frame: 17 weeks
Phase 2 Part 5: Change from baseline in total GLP-1 in adult participants with Type 1 diabetes
Time frame: 17 weeks
Phase 2 Part 5: Change from baseline in plasma C-peptide in adult participants with Type 1 diabetes
Time frame: 17 weeks
Phase 2 Part 5: To characterize the PK profile of oral PAL-119 in participants with Type 1 diabetes-trough at steady state
Time frame: 17 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Not yet recruitingPhase 1
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses
Weight Management, Type 2 Diabetes
RecruitingPhase 1
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PAL-119 in people with Healthy Volunteers and Diabetes Participants, run by Paulex Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Part 1: Safety and tolerability of PAL-119 in healthy volunteers (time frame: 8 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.