A Phase 1/2 interventional study of PAL-119 and Placebo in Healthy Volunteers and Diabetes Participants, sponsored by Paulex Bio Inc.. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Paulex Bio Inc. · Phase 1/2, Interventional, and Treatment
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
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:
Phase 2a in adult participants with diabetes
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 147 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →This is the only study on the registry with Paulex Bio Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1 Parts 1, 2 and 3
Phase 2 Part 4:
Phase 2 Part 5
Exclusion Criteria:
Phase 1 Parts 1, 2 and 3:
Phase 2 Part 4:
Phase 2 Part 5:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: PAL-119
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
Drug: Placebo
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
Drug: PAL-119
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
Drug: Placebo
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.
Drug: PAL-119
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.
Drug: PAL-119
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.
Drug: Placebo
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.
Drug: PAL-119
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.
Drug: Placebo
Small synthetic molecule
Placebo
Phase 1 Part 1: Safety and tolerability of PAL-119 in healthy volunteers
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 17 weeks
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%
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
The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time.
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
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
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
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
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
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%
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
The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time
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
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
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
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
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
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%
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
The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
Time frame: 17 weeks
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 44 phase 1/2 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 93. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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