A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.

ProGen. Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Healthy

Treatments: Drug: PG-102(MG12); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06309667

SL-MG12-P1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 11 patient groups

Cohort A1 - Single Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 1 (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort A2 - Single Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 2 (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort A3 - Single Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 3 (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort A4 - Single Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 4 (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort A5 - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 5 (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort B1 - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 1 (N=6) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort B2 - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort B3 - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort S - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort C1 - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 1 (N=12) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)

Cohort C2 - Multiple Ascending Dose

Experimental group

Description:

PG-102(MG12) Dose 1 (N=12) Subcutaneous injection

Treatment:

Other: Placebo

Drug: PG-102(MG12)