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Healthy SubjectsPhase 1NCT05476094

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

A Phase 1 study testing Polyene Phosphatidylcholine in people with Healthy Subjects and Submental Fat, run by AMIpharm Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Submental Fat
What is being tested?
Polyene Phosphatidylcholine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteSouth Korea
Study dates
10 Aug 2022to 23 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female equal to or greater than 19 and equal to or less than 65 years old
  • 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)
  • BMI(Body Mass Index, kg/m^2) - 19.0 or more and less than 35.0
  • agree to contraception through medically permitted contraceptive methods during clinical trial (three months after final administration) among potentially pregnant men and women
  • agree not to donate or transfuse blood (including whole blood, plasma components, platelet components, and platelet plasma components) during clinical trial
  • 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
  • Singed informed consent with full understanding of this clinical trial
  • A healthy person who does not have clinically significant findings in the clinical laboratory test, vital signs, and physical examination

Who cannot join

  • Allergic to beans, lidocaine or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.)
  • Central, endocrine, or hereditary obesity (BMI 35kg/m^2 or more)
  • History of any treatment (orthognathic surgery, suction lipectomy, PPC injection) in the neck or chin area
  • Inflammation, scars or surgery on the injection area
  • history of dysphagia or current symptoms of dysphagia
  • Clinical laboratory tests and electrocardiogram results performed during screening visit are clinically significant abnormal factors.
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  • 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)]
  • Positive results of virus tests (HBV, HCV, HIV) performed during screening visit
  • Positive results of syphilis test (RPR) performed during screening visit
  • 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
  • Diagnosis of heart disease (cardiac failure, unstable angina, myocardial infarction) or stroke within 6 months before screening
  • 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
  • history of systemic hives within 5 years before IP administration
  • history of genetic or idiopathic vascular neuropathy
  • organ or bone marrow transplantation
  • suspected of drug abuse or alcohol abuse or has a history within six months before IP administration
  • 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)
  • 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
  • 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)
  • continue to drink (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot abstain from drinking during the clinical trial
  • Smokers (in some cases, smoking up to 10 cigarettes/day is acceptable at the discretion of PI)
  • have participated in other clinical trials (including live trials) within 6 months before IP administration
  • 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
  • has donated the following blood prior to the first date of administration
  • Whole blood; 2 months; component blood donation; within 1 month
  • a pregnant or lactating woman
  • has determined that PI is not eligible for this clinical trial due to other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

Other trials in South Korea

About this study

Official title: 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

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.

Being tested
Polyene Phosphatidylcholine
Keywords
submental fat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyene PhosphatidylcholineDrug

    Also called AYP-101 1, AYP-101 2, Placebo

    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

Study groups in NCT05476094
Study groupRoleWhat they receive
Experimental: AYP-101 1Experimental0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration
Receives: Drug: Polyene Phosphatidylcholine
Experimental: AYP-101 2Experimental0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration
Receives: Drug: Polyene Phosphatidylcholine
PlaceboPlacebo comparator0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration
Receives: Drug: Polyene Phosphatidylcholine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    AE to the localized injection area or total body)

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

Secondary outcomes (2)

  1. Pharmacokinetics- Cmax of DLPC(IPsurface substances)

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

    Measured: 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)

    Measured: baseline IP treatment, Amount of change

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start10 Aug 2022
  3. Primary completion16 Aug 2023
  4. Study completion23 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476094
Sponsor's protocol ID
AYP-101-101
Status last verified
Jan 2026
First submitted
15 Jul 2022
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Polyene Phosphatidylcholine in people with Healthy Subjects and Submental Fat, run by AMIpharm Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety- Number of adverse event, incidence of adverse event (time frame: IP treatment~ the end visit of the clinical trial : 28 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05476094, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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