Hemoglobinopathy
Conditions
Brief summary
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.
Interventions
DRUGSNH-119014
study drug
DRUGPlacebo
placebo
Sponsors
ScinnoHub Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment | up to 7 days or 20 days | Safety and Tolerability |
Countries
China
Contacts
Primary ContactWei Hu, Ph.D
Outcome results
None listed