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

NCT05476094 | Completed Phase 1

• 1 other identifier: AYP-101-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Subjects; Submental Fat

Keywords

submental fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetics- Cmax of DLPC(IPsurface substances)

  baseline IP treatment, Amount of change

• Pharmacokinetics- AUC of DLPC(IPsurface substances)

  baseline IP treatment, Amount of change

Study Arms (3)

Experimental: AYP-101 1

EXPERIMENTAL

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

Drug: Polyene Phosphatidylcholine

Experimental: AYP-101 2

EXPERIMENTAL

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

Drug: Polyene Phosphatidylcholine

Placebo

PLACEBO COMPARATOR

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

Drug: Polyene Phosphatidylcholine

Interventions

Polyene Phosphatidylcholine DRUG

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

Experimental: AYP-101 1; Experimental: AYP-101 2; Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• AMIpharm Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39732703 DERIVED

MeSH Terms

Interventions

polyene phosphatidylcholine

Study Officials

• Jae Yong Chung, M.D.,Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 27, 2022
• Study Start: August 10, 2022
• Primary Completion: August 16, 2023
• Study Completion: August 23, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)