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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309667
• Other study ID #: SL-MG12-P1
• Status: Recruiting
• Phase: Phase 1
• Start date: October 17, 2023
• Est. completion date: June 26, 2024

Study information

• Verified date: February 2024
• Source: ProGen. Co., Ltd.
• Contact: Kyunghwa Son, Ph.D
• Phone: 02-6098-2818
• Email: bd[@]progen.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

Drug:
• PG-102(MG12)
GLP-1 and GLP-2 fusion protein
• Placebo
Placebo drug of PG-102(MG12)

Locations

Country	Name	City	State
Korea, Republic of	Catholic University Seoul St.Mary Hospital,	Seocho	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
ProGen. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Maximum plasma concentration (Cmax) for Part A	Maximum plasma concentration (Cmax)	Baseline to Day 29
Secondary	Maximum plasma concentration (Cmax) for Part B	Maximum plasma concentration (Cmax)	Baseline to Day 57
Secondary	Time to maximum plasma concentration (tmax) for Part A	Time to maximum plasma concentration (tmax)	Baseline to Day 29
Secondary	Time to maximum plasma concentration (tmax) for Part B	Time to maximum plasma concentration (tmax)	Baseline to Day 57
Secondary	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
Secondary	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
Secondary	Terminal half-life (t1/2) for Part A	Terminal half-life (t1/2)	Baseline to Day 29
Secondary	Terminal half-life (t1/2) for Part B	Terminal half-life (t1/2)	Baseline to Day 57
Secondary	Apparent total clearance (CL/F) for Part A	Apparent total clearance (CL/F)	Baseline to Day 29
Secondary	Apparent total clearance (CL/F) for Part B	Apparent total clearance (CL/F)	Baseline to Day 57