A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers

A Double-blind, Randomized, Placebo Controlled, Combined Single and Multiple Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers

This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) 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 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5).

Study Overview

• Status: Recruiting
• Conditions: Healthy; Overweight
• Intervention / Treatment: Drug: PG-102(MG12); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kyunghwa Son, Ph.D; Phone Number: 02-6098-2818; Email: bd@progen.co.kr

Study Locations

• Korea, Republic of
  • Seoul
    • Seocho, Seoul, Korea, Republic of, 06591
      • Recruiting
      • Catholic University Seoul St.Mary Hospital,
      • Contact: Kyunghwa Son, Ph.D; Phone Number: 02-6098-2818; Email: bd@progen.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 and Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B

[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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A1 - Single Ascending Dose; PG-102(MG12) Dose 1 (N=8) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort A2 - Single Ascending Dose; PG-102(MG12) Dose 2 (N=8) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort A3 - Single Ascending Dose; PG-102(MG12) Dose 3 (N=8) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort A4 - Single Ascending Dose; PG-102(MG12) Dose 4 (N=8) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort A5 - Multiple Ascending Dose; PG-102(MG12) Dose 5 (N=8) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort B1 - Multiple Ascending Dose; PG-102(MG12) Dose 1 (N=6) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort B2 - Multiple Ascending Dose; PG-102(MG12) Dose 1~5 (N=6) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort B3 - Multiple Ascending Dose; PG-102(MG12) Dose 1~5 (N=6) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort B4 - Multiple Ascending Dose; PG-102(MG12) Dose 1~5 (N=6) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)
Experimental: Cohort S - Multiple Ascending Dose; PG-102(MG12) Optimal Dose (N=6) Placebo (N=2) Subcutaneous injection	Drug: PG-102(MG12); GLP-1 and GLP-2 fusion protein; Drug: Placebo; Placebo drug of PG-102(MG12)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: ProGen. Co., Ltd.
• Investigators: Principal Investigator: Seunghoon Han, MD, Catholic University Seoul St.Mary Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): June 26, 2024
• Study Completion (Estimated): June 26, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: SL-MG12-P1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No