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CompletedNCT05476094Updated Jan 22, 2026

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

A Phase 1 interventional study of Polyene Phosphatidylcholine in Healthy Subjects and Submental Fat, sponsored by AMIpharm Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by AMIpharm Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Healthy Subjects
  • Submental Fat

Keywords

  • submental fat
03

In context

Lead sponsor

AMIpharm Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Experimental: AYP-101 1

    0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration

    Drug: Polyene Phosphatidylcholine

  • Experimental
    Experimental: AYP-101 2

    0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration

    Drug: Polyene Phosphatidylcholine

  • Placebo comparator
    Placebo

    0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration

    Drug: Polyene Phosphatidylcholine

Interventions

  • DrugPolyene 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

    Also known as: AYP-101 1, AYP-101 2, Placebo

06

What researchers measure

Primary outcomes

  1. Safety- Number of adverse event, incidence of adverse event

    AE to the localized injection area or total body)

    Time frame: IP treatment~ the end visit of the clinical trial : 28 day

Secondary outcomes

  1. Pharmacokinetics- Cmax of DLPC(IPsurface substances)

    Peak Plasma Concentration(Cmax), Tmax etc. of DLPC(IP surface substances)

    Time frame: baseline IP treatment, Amount of change

  2. Pharmacokinetics- AUC of DLPC(IPsurface substances)

    Area under the plasma concentration versus time curve(AUC) of DLPC(IPsurface substances)

    Time frame: baseline IP treatment, Amount of change

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Gyeonggi-do, 13620, South Korea
08

References and documents

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. PubMed 39732703 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05476094
Lead sponsor
AMIpharm Co., Ltd.
Responsible party
Sponsor
First posted
Jul 27, 2022
Start date
Aug 10, 2022
Primary completion
Aug 16, 2023
Completion
Aug 23, 2023
Last update
Jan 22, 2026

Study contacts

Jae Yong Chung, M.D.,Ph.D
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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