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
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
This study is planed to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. injection in Healthy Subjects.
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.
Exclusion Criteria:
Clinical laboratory tests and electrocardiogram results performed during screening visit are clinically significant abnormal factors.
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
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)
has donated the following blood prior to the first date of administration
- Whole blood; 2 months; component blood donation; within 1 month
0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration
Drug: Polyene Phosphatidylcholine
0.2 mL injections, 1.0 cm apart, up to 10.0 ml, Single administration
Drug: Polyene Phosphatidylcholine
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
Also known as: AYP-101 1, AYP-101 2, Placebo
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
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
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
Plan to share: No
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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AMIpharm Co., Ltd.