Status:

RECRUITING

A Phase I Study of SNH-119014 in Healthy Volunteers

Lead Sponsor:

ScinnoHub Pharmaceutical Co., Ltd.

Conditions:

Hemoglobinopathy

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

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, to...

Eligibility Criteria

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.

Key Trial Info

Start Date :

June 27 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 28 2026

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT07087262

Start Date

June 27 2025

End Date

March 28 2026

Last Update

July 25 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The Second Hospital of Anhui Medical University

Hefei, Anhui, China, 230601

A Phase I Study of SNH-119014 in Healthy Volunteers | DecenTrialz