Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose Phase Ⅰ Study to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. Injection in Healthy Subjects

To Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. injection in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Submental Fat
• Intervention / Treatment: Drug: Polyene Phosphatidylcholine

Detailed Description

This study is planed to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. injection in Healthy Subjects.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male and female equal to or greater than 19 and equal to or less than 65 years old
2. submental fat under the chin capable of a single S.C. injection - 50 points at intervals of 1.0 cm grid pattern (90% or more, i.e. a minimum of 45 points, if not enough points)
3. BMI(Body Mass Index, kg/m^2) - 19.0 or more and less than 35.0
4. agree to contraception through medically permitted contraceptive methods during clinical trial (three months after final administration) among potentially pregnant men and women
5. agree not to donate or transfuse blood (including whole blood, plasma components, platelet components, and platelet plasma components) during clinical trial
6. agree not to receive adiposeform therapy (fat inhalation, surgery, etc.) or cosmetic surgery (botox, filler, laser, high frequency, etc.) at other sites of administration during clinical trial
7. Singed informed consent with full understanding of this clinical trial
8. A healthy person who does not have clinically significant findings in the clinical laboratory test, vital signs, and physical examination

Exclusion Criteria:

1. Allergic to beans, lidocaine or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.)
2. Central, endocrine, or hereditary obesity (BMI 35kg/m^2 or more)
3. History of any treatment (orthognathic surgery, suction lipectomy, PPC injection) in the neck or chin area
4. Inflammation, scars or surgery on the injection area
5. history of dysphagia or current symptoms of dysphagia

6. Clinical laboratory tests and electrocardiogram results performed during screening visit are clinically significant abnormal factors.

   • Total Cholesterol > 250 mg/dl, LDL-C > 160 mg/dL, TG > 200 mg/dL
   • AST, ALT, γ-GT > 2x the upper limit of the normal range
   • CK > 2.5 times the upper limit of the normal range
   • eGFR (MDRD) <60 ml/min/1.73m2,MDRD=175*Scr[exp(-1.154)]*AGE[exp(-0.203)]*[0.742 (for women)]
7. Positive results of virus tests (HBV, HCV, HIV) performed during screening visit
8. Positive results of syphilis test (RPR) performed during screening visit

9. unable to participate by the tester due to serious medical or psychiatric diseases falling under the following conditions

   ① Respiratory diseases: People who need to take daily medication such as asthma, chronic obstructive pulmonary disease (COPD), active tuberculosis, latent tuberculosis under treatment, etc

   • Severe cardiovascular disease: congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled high blood pressure, myocarditis, pericarditis, etc

     • Neurological disorders: Epilepsy, Seizure (within 3 years prior to clinical trial medication), stroke, encephalopathy, Guillain-Barre syndrome, encephalomyelitis, transverse spondylitis, etc

       • Malignant tumor history within 5 years before IP administration of clinical trial drugs (except for basal cell and squamous cell carcinoma) ⑤ Autoimmune hypothyroidism and autoimmune diseases including psoriasis ⑥ Immunodeficiency disease ⑦Other diseases such as the hepatobiliary, kidney, endocrine system, urology, and musculoskeletal system that were determined to be clinically significant by PI
10. Diagnosis of heart disease (cardiac failure, unstable angina, myocardial infarction) or stroke within 6 months before screening
11. Administration of anticoagulants or anticoagulants with a history of platelet-related or hemorrhagic diseases or a history of severe bleeding or bruising after previous subcutaneous injection
12. history of systemic hives within 5 years before IP administration
13. history of genetic or idiopathic vascular neuropathy
14. organ or bone marrow transplantation
15. suspected of drug abuse or alcohol abuse or has a history within six months before IP administration

16. uses immunosuppressants and immunomodulators or chronically uses steroids within 6 months before IP administration

    ① Immunosuppressants and regulators : : Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate, Rapamycin, Leflunomide etc.

    ② Systemic steroids: If a dose of more than 10 mg/day based on Prednisolone is used for more than 14 consecutive days (but steroids, nasal sprays, inhalants and eye drops are allowed regardless of the volume of use)

17. history of dependent administration of psychotropic drugs or narcotic painkillers within 6 months before IP administration or who is mentally ill or in a social condition that is difficult to comply with clinical trial procedures at the discretion of PI
18. taken any ETC drug or herbal medicine within two weeks prior to the first dose date, or who has taken any general drug (OTC drug) or fish oil preparation (Omega3) within one week (but may participate in clinical trials if other conditions are reasonable)
19. continue to drink (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot abstain from drinking during the clinical trial
20. Smokers (in some cases, smoking up to 10 cigarettes/day is acceptable at the discretion of PI)
21. have participated in other clinical trials (including live trials) within 6 months before IP administration
22. has been administered immunoglobulin or blood-derived drugs within three months before IP administration, or a person who has plans to administer them during the clinical trial period

23. has donated the following blood prior to the first date of administration

    - Whole blood; 2 months; component blood donation; within 1 month

24. a pregnant or lactating woman
25. has determined that PI is not eligible for this clinical trial due to other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: AYP-101 1; 0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration	Drug: Polyene Phosphatidylcholine; AYP-101 1 - 25 mg of essential phospholipids in 1 mL AYP-101 2 - 50 mg of essential phospholipids in 1 mL Placebo - Essential phospholipids in 1 mL 00 mg; Other Names: Placebo; AYP-101 1; AYP-101 2
Experimental: Experimental: AYP-101 2; 0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration	Drug: Polyene Phosphatidylcholine; AYP-101 1 - 25 mg of essential phospholipids in 1 mL AYP-101 2 - 50 mg of essential phospholipids in 1 mL Placebo - Essential phospholipids in 1 mL 00 mg; Other Names: Placebo; AYP-101 1; AYP-101 2
Placebo Comparator: Placebo; 0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration	Drug: Polyene Phosphatidylcholine; AYP-101 1 - 25 mg of essential phospholipids in 1 mL AYP-101 2 - 50 mg of essential phospholipids in 1 mL Placebo - Essential phospholipids in 1 mL 00 mg; Other Names: Placebo; AYP-101 1; AYP-101 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety- Number of adverse event, incidence of adverse event	AE to the localized injection area or total body)	IP treatment~ the end visit of the clinical trial : 28 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics- Cmax of DLPC(IPsurface substances)	Peak Plasma Concentration(Cmax), Tmax etc. of DLPC(IP surface substances)	baseline IP treatment, Amount of change
Pharmacokinetics- AUC of DLPC(IPsurface substances)	Area under the plasma concentration versus time curve(AUC) of DLPC(IPsurface substances)	baseline IP treatment, Amount of change

Collaborators and Investigators

• Sponsor: AMIpharm Co., Ltd.
• Investigators: Principal Investigator: Jae Yong Chung, M.D.,Ph.D, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Lee HJ, Jiang X, Abd El-Aty AM, Jeong JH, Chung JY. Phase 1 study of AYP-101 (soybean phosphatidylcholine): safety, pharmacokinetics, and lipid profile effects for reducing submental fat. Lipids Health Dis. 2024 Dec 28;23(1):426. doi: 10.1186/s12944-024-02387-4.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: submental fat
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; polyene phosphatidylcholine
• Other Study ID Numbers: AYP-101-101

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