Clinical trial NCT06309667: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.
Official title: A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and 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 and Obesity Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Overweight
Lead sponsor: ProGen. Co., Ltd.
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part A
timeFrame: Baseline to Day 29
measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part B
timeFrame: Baseline to Day 57
measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A
timeFrame: Baseline to Day 29
measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B
timeFrame: Baseline to Day 57
measure: Number of participants with clinically significant abnormalities in vital signs for Part A
timeFrame: Baseline to Day 29
measure: Number of participants with clinically significant abnormalities in vital signs for Part B
timeFrame: Baseline to Day 57
measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A
timeFrame: Baseline to Day 29
measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B
timeFrame: Baseline to Day 57
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) for Part A
timeFrame: Baseline to Day 29
measure: Maximum plasma concentration (Cmax) for Part B
timeFrame: Baseline to Day 57
measure: Time to maximum plasma concentration (tmax) for Part A
timeFrame: Baseline to Day 29
measure: Time to maximum plasma concentration (tmax) for Part B
timeFrame: Baseline to Day 57
measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A
timeFrame: Baseline to Day 29
measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B
timeFrame: Baseline to Day 57
measure: Terminal half-life (t1/2) for Part A
timeFrame: Baseline to Day 29
measure: Terminal half-life (t1/2) for Part B
timeFrame: Baseline to Day 57
measure: Apparent total clearance (CL/F) for Part A
timeFrame: Baseline to Day 29
measure: Apparent total clearance (CL/F) for Part B
timeFrame: Baseline to Day 57
Other outcomes:
Locations:
city: Seocho
country: Korea, Republic of
facility: Catholic University Seoul St.Mary Hospital,
state: Seoul
Study officials:
affiliation: Catholic University Seoul St.Mary Hospital
name: Seunghoon Han, MD
role: PRINCIPAL_INVESTIGATOR
References: