A Phase I Study of SNH-119014 in Healthy Volunteers

ScinnoHub Pharmaceutical Co., Ltd.

Status and phase

Enrolling

Phase 1

Conditions

Hemoglobinopathy

Treatments

Drug: SNH-119014

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07087262

SNH-119014-101

Details and patient eligibility

About

SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of SNH-119014 in the context of Phase 1 studies in healthy volunteers. The effects of food on the absorption of SNH-119014 will also be evaluated in healthy volunteers.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female subjects;
18-45 years of age, inclusive;
Male subjects with body weight ≥50 kg, female subjects with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.
Must provide written informed consent.

Exclusion criteria

History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, ophthalmology, hematology, immunology, psychiatry disorder, as judged by the investigator；
Subjects who have undergone major surgery 6 months prior to screening or who plan to undergo surgery during the study period;
Clinically significant abnormal physical examination, vital signs, chest X-ray, laboratory tests during the screening period as judged by the investigator;
Subjects with QTcF>450 ms, or with other ECG clinically significant abnormalities during the screening period as judged by the investigator;
Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody at screening;
Subjects who have a known chronic liver disease, or who have clinically significant abnormal liver function test results during the screening period;
History of urinary system diseases.
History of dysphagia or any gastrointestinal disorder affecting drug absorption.
History of malignancy.
History of severe allergies or allergic to the study drug or any of its components. Serious adverse reaction or hypersensitivity to any drug or the formulation excipients.
Failure to follow a consistent diet.
Over 5 cups (200 ml per cup) of tea, coffee, or caffeinated beverages were consumed daily during the 3 months prior to screening.
Consumption of a specific diet (e.g. grapefruit and grapefruit-containing products, chocolate, any food containing caffeine), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion within 48 hours before the dose of study drug.
Subjects who have taken any drugs that alter the activity of liver enzymes and/or transporters within 28 days prior to screening.
Females who are pregnant or lactating and subjects who are unable to use one or more nonpharmacological contraceptives.
Subjects who have taken any prescribed or over-the-counter drug or herbal remedies or nutraceutical product within 14 days before the dose of study drug.
Subjects who smoked more than 5 cigarettes per day during the 3 months prior to screening, or who cannot accept a smoking ban throughout the study.
Alcohol intake >14 units per week within 6 months prior to screening (1 unit is equal to 14g of alcohol such as 360mL of beer, 45mL of 40% spirit, 150mL of wine, or a confirmed positive alcohol breath test, or alcohol prohibition is not acceptable throughout the study.
History of drug abuse in the past 1 year prior to screening, or a confirmed positive drugs of abuse test result before randomization.
Subjects who plan to conceive or donate sperm or eggs during the study or within 3 months after completion of study.
Subjects has received study drug in another clinical study within 3 months before the dose of study drug.
Subjects who have donated blood or loss ≥400 mL of blood within 3 months before the dose of study drug, or who plan to donate blood or blood components during the study or within 3 months after completion of study.
Subjects who have received a live attenuated vaccine within 28 days before the dose of study drug.
Subjects who cannot tolerate venipuncture, or those with a history of needle fainting or blood fainting.
In the opinion of the investigator, the subject is not suitable for entry into the study.