Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers

Sinew Pharma

Status and phase: Completed; Phase 1

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: HUYPS-1 nine tablets; Drug: HUYPS-1 one tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05983328

Oral HUYPS-1-001

Details and patient eligibility

About

Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period.

Period: 24 hours post dose in each period. Each subject will complete two study periods.

Washout Period: At least one week after dosing of the previous period.

Confinement: From at least 10 hours prior to dosing until at least 12 hours post-dose, for a total of at least 22 hours for each study period.

Full description

This study is a single center and open-label design to evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after single oral administration in healthy subjects under fasting conditions. A total of 14 eligible subjects are expected to be enrolled to ensure 12 evaluable subjects. The study will be completed when there are at least 12 evaluable subjects. The evaluable subjects are those who have completed both periods. Eligible subjects will be randomly assigned to either of the two treatment sequences.

The study design in a 2-sequence, 2-period crossover design. There is at least 7-day washout time between periods. The formulation of HUYPS-1 for oral administration contains 100 mg mannitol and 100 mg sucralose per tablet will be given by one or nine tablets per person of each period. Mannitol and sucralose are both commonly used excipients approved by WHO. These excipients are included in the FDA Inactive Ingredients Guide, GRAS (generally recognized as safe) and commonly used pharmaceutical excipients, therefore the oral doses of these excipients can be regarded as extremely safe in this study.

Enrollment: 14 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Normal healthy adult subjects between 20-50 years of age.
2. Acceptable medical history and physical examination including:
3. 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).
4. 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.
5. Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
6. Signed the written informed consent to participate in this study.
7. Acceptable body mass index (BMI): 18.5 < BMI < 25 kg/m2

Exclusion criteria

1. Recent history of drug or alcohol addiction or abuse within the past year.
2. 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).
3. History of allergic response(s) to mannitol, sucralose or related drugs.
4. History of clinically significant allergies including drug allergies or allergic bronchial asthma.
5. Evidence of chronic or acute infectious diseases.
6. Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).
7. Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
8. Receiving any investigational drug within one month prior to Period I dosing.
9. Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
10. 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.
11. 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.
12. Any other medical reason as determined by the clinical investigator.
13. Subject is pregnant or breastfeeding.
14. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Healthy Volunteers dose 1

Experimental group

Description:

Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 1 tablet oral administration in healthy subjects

Treatment:

Drug: HUYPS-1 one tablet

Healthy Volunteer dose 2

Experimental group

Description:

Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 9 tablets oral administration in healthy subjects

Treatment:

Drug: HUYPS-1 nine tablets