A Phase I Study of SNH-119014 in Healthy Volunteers

NCT ID: NCT07087262

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2026-03-28

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.

Conditions

Hemoglobinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

SNH-119014

Group Type: EXPERIMENTAL

SNH-119014

Intervention Type: DRUG

study drug

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

SNH-119014

study drug

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ScinnoHub Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Hu, Ph.D

Role: CONTACT

huwei@ahmu.edu.com

86010-3856086475

Facility Contacts

Wei Hu, Ph.D

Role: primary

huwei@ahmu.edu.com

86010-3856086475

Other Identifiers

SNH-119014-101

Identifier Type: -

Identifier Source: org_study_id