Healthy, Overweight
Conditions
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.
Interventions
DRUGPG-102(MG12)
GLP-1 and GLP-2 fusion protein
OTHERPlacebo
Placebo drug of PG-102(MG12)
Sponsors
ProGen. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent 2. 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 \[
Exclusion criteria
\] 1. 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. 2. 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. 3. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy. 4. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| Apparent total clearance (CL/F) for Part A | Baseline to Day 29 | Apparent total clearance (CL/F) |
| Maximum plasma concentration (Cmax) for Part A | Baseline to Day 29 | Maximum plasma concentration (Cmax) |
| Apparent total clearance (CL/F) for Part B | Baseline to Day 57 | Apparent total clearance (CL/F) |
| Maximum plasma concentration (Cmax) for Part B | Baseline to Day 57 | Maximum plasma concentration (Cmax) |
| Time to maximum plasma concentration (tmax) for Part A | Baseline to Day 29 | Time to maximum plasma concentration (tmax) |
| Time to maximum plasma concentration (tmax) for Part B | Baseline to Day 57 | 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) |
| 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) |
| Terminal half-life (t1/2) for Part A | Baseline to Day 29 | Terminal half-life (t1/2) |
| Terminal half-life (t1/2) for Part B | Baseline to Day 57 | Terminal half-life (t1/2) |
Countries
South Korea
Outcome results
None listed