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This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.
This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.
Part A (SAD):
In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.
Part B (MAD):
In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.
Part C (MAD):
In Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=8) Subcutaneous injection |
|
| Cohort A2 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 2 (N=8) Subcutaneous injection |
|
| Cohort A3 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 3 (N=8) Subcutaneous injection |
|
| Cohort A4 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 4 (N=8) Subcutaneous injection |
|
| Cohort A5 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 5 (N=8) Subcutaneous injection |
|
| Cohort B1 - Multiple Ascending Dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG-102(MG12) | Drug | GLP-1 and GLP-2 fusion protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) for Part A | Number of participants with treatment-emergent adverse events (TEAEs) | Baseline to Day 29 |
| Number of participants with treatment-emergent adverse events (TEAEs) for Part B | Number of participants with treatment-emergent adverse events (TEAEs) | Baseline to Day 57 |
| Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A | Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 | Baseline to Day 29 |
| Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B | Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 | Baseline to Day 57 |
| Number of participants with clinically significant abnormalities in vital signs for Part A | Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius) | Baseline to Day 29 |
| Number of participants with clinically significant abnormalities in vital signs for Part B | Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius) | Baseline to Day 57 |
| Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) for Part A | Maximum plasma concentration (Cmax) | Baseline to Day 29 |
| Maximum plasma concentration (Cmax) for Part B | Maximum plasma concentration (Cmax) |
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Inclusion Criteria:
[Exclusion Criteria]
History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).
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| Name | Affiliation | Role |
|---|---|---|
| Seunghoon Han, MD | Catholic University Seoul St.Mary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University Seoul St.Mary Hospital, | Seocho | Seoul | 06591 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41876542 | Derived | Yang SI, Kim SW, Son KH, Lee SA, Kim JG, Roh JI, Sung YC. Bispecific GLP-1/GLP-2 agonism in advanced type 2 diabetes: preclinical characterization and a randomized, double-blind, placebo-controlled phase I trial. Nat Commun. 2026 Mar 24;17(1):4477. doi: 10.1038/s41467-026-71080-0. |
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PG-102(MG12) Dose 1 (N=6) Subcutaneous injection |
|
| Cohort B2 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection |
|
| Cohort B3 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection |
|
| Cohort S - Multiple Ascending Dose | Experimental | PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection |
|
| Cohort C1 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=12) Subcutaneous injection |
|
| Cohort C2 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=12) Subcutaneous injection |
|
| Placebo | Other | Placebo drug of PG-102(MG12) |
|
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
| Baseline to Day 29 |
| Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B | Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec) | Baseline to Day 57 |
| Baseline to Day 57 |
| Time to maximum plasma concentration (tmax) for Part A | Time to maximum plasma concentration (tmax) | Baseline to Day 29 |
| Time to maximum plasma concentration (tmax) for Part B | Time to maximum plasma concentration (tmax) | Baseline to Day 57 |
| Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A | Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) | Baseline to Day 29 |
| Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B | Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) | Baseline to Day 57 |
| Terminal half-life (t1/2) for Part A | Terminal half-life (t1/2) | Baseline to Day 29 |
| Terminal half-life (t1/2) for Part B | Terminal half-life (t1/2) | Baseline to Day 57 |
| Apparent total clearance (CL/F) for Part A | Apparent total clearance (CL/F) | Baseline to Day 29 |
| Apparent total clearance (CL/F) for Part B | Apparent total clearance (CL/F) | Baseline to Day 57 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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