Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volun... | NCT05983328

NCT05983328

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Volunteers dose 1	Experimental	Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 1 tablet oral administration in healthy subjects	Drug: HUYPS-1 one tablet
Healthy Volunteer dose 2	Experimental	Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 9 tablets oral administration in healthy subjects	Drug: HUYPS-1 nine tablets

Name	Type	Description	Arm Group Labels	Other Names
HUYPS-1 one tablet	Drug	After 7-day washout time, subjects will receive HUYPS-1 1 tablet.	Healthy Volunteers dose 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile of maximum concentration of HUYPS-1 (Cmax)	Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: Cmax

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal healthy adult subjects between 20-50 years of age.
Acceptable medical history and physical examination including:
Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and galactose single point (GSP).
Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
Signed the written informed consent to participate in this study.
Acceptable body mass index (BMI): 18.5 < BMI < 25 kg/m2

Exclusion Criteria:

Recent history of drug or alcohol addiction or abuse within the past year.
A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
History of allergic response(s) to mannitol, sucralose or related drugs.
History of clinically significant allergies including drug allergies or allergic bronchial asthma.
Evidence of chronic or acute infectious diseases.
Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).
Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
Receiving any investigational drug within one month prior to Period I dosing.
Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
Donating greater than 150 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol, smoke or use tobacco products within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
Any other medical reason as determined by the clinical investigator.
Subject is pregnant or breastfeeding.
Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases