A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.
- Registration Number
- NCT06309667
- Lead Sponsor
- ProGen. Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
- Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C
[Exclusion Criteria]
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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:
- Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
- Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
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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.
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History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
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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).
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A5 - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Dose 5 (N=8) Subcutaneous injection Cohort B1 - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Dose 1 (N=6) Subcutaneous injection Cohort S - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection Cohort C1 - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Dose 1 (N=12) Subcutaneous injection Cohort C2 - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Dose 1 (N=12) Subcutaneous injection Cohort A1 - Single Ascending Dose PG-102(MG12) PG-102(MG12) Dose 1 (N=8) Subcutaneous injection Cohort A1 - Single Ascending Dose Placebo PG-102(MG12) Dose 1 (N=8) Subcutaneous injection Cohort A2 - Single Ascending Dose PG-102(MG12) PG-102(MG12) Dose 2 (N=8) Subcutaneous injection Cohort A2 - Single Ascending Dose Placebo PG-102(MG12) Dose 2 (N=8) Subcutaneous injection Cohort A3 - Single Ascending Dose PG-102(MG12) PG-102(MG12) Dose 3 (N=8) Subcutaneous injection Cohort A3 - Single Ascending Dose Placebo PG-102(MG12) Dose 3 (N=8) Subcutaneous injection Cohort A4 - Single Ascending Dose PG-102(MG12) PG-102(MG12) Dose 4 (N=8) Subcutaneous injection Cohort A4 - Single Ascending Dose Placebo PG-102(MG12) Dose 4 (N=8) Subcutaneous injection Cohort A5 - Multiple Ascending Dose Placebo PG-102(MG12) Dose 5 (N=8) Subcutaneous injection Cohort B1 - Multiple Ascending Dose Placebo PG-102(MG12) Dose 1 (N=6) Subcutaneous injection Cohort B2 - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection Cohort B2 - Multiple Ascending Dose Placebo PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection Cohort B3 - Multiple Ascending Dose PG-102(MG12) PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection Cohort B3 - Multiple Ascending Dose Placebo PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection Cohort S - Multiple Ascending Dose Placebo PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection Cohort C1 - Multiple Ascending Dose Placebo PG-102(MG12) Dose 1 (N=12) Subcutaneous injection Cohort C2 - Multiple Ascending Dose Placebo PG-102(MG12) Dose 1 (N=12) Subcutaneous injection
- Primary Outcome Measures
Name Time Method Number of participants with clinically significant abnormalities in vital signs for Part A Baseline to Day 29 Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Number of participants with clinically significant abnormalities in vital signs for Part B Baseline to Day 57 Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Number of participants with treatment-emergent adverse events (TEAEs) for Part A Baseline to Day 29 Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B Baseline to Day 57 Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with treatment-emergent adverse events (TEAEs) for Part B Baseline to Day 57 Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A Baseline to Day 29 Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A Baseline to Day 29 Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B Baseline to Day 57 Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
- Secondary Outcome Measures
Name Time Method Terminal half-life (t1/2) for Part A Baseline to Day 29 Terminal half-life (t1/2)
Maximum plasma concentration (Cmax) for Part B Baseline to Day 57 Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) for Part A Baseline to Day 29 Maximum plasma concentration (Cmax)
Time to maximum plasma concentration (tmax) for Part A Baseline to Day 29 Time to maximum plasma concentration (tmax)
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A Baseline to Day 29 Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Terminal half-life (t1/2) for Part B Baseline to Day 57 Terminal half-life (t1/2)
Time to maximum plasma concentration (tmax) for Part B Baseline to Day 57 Time to maximum plasma concentration (tmax)
Apparent total clearance (CL/F) for Part A Baseline to Day 29 Apparent total clearance (CL/F)
Apparent total clearance (CL/F) for Part B Baseline to Day 57 Apparent total clearance (CL/F)
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B Baseline to Day 57 Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Trial Locations
- Locations (1)
Catholic University Seoul St.Mary Hospital,
🇰🇷Seocho, Seoul, Korea, Republic of