Phase 1 testing of oral SNH-119014 in healthy adults
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers
Run by ScinnoHub Pharmaceutical Co., Ltd. · NCT07087262 · Data updated 2026-11-12
This Phase 1 test gives single and multiple oral doses of SNH-119014 to healthy adults to see if it is safe, tolerated, and how the body absorbs and processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | ScinnoHub Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | June 27, 2025 |
| Main results expected | March 28, 2026 |
| Study ends | March 28, 2026 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT07087262 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are healthy men or women aged 18–45 who meet the study's weight and BMI requirements and have no clinically significant medical problems on screening.
✕Probably not a fit
Patients with existing hemoglobinopathies or other medical conditions are unlikely to receive therapeutic benefit from this healthy-volunteer Phase 1 study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SNH-119014 is an oral small-molecule activator of red blood cell pyruvate kinase (PKR) being developed for hemolytic anemias. This Phase 1, placebo-controlled study enrolls healthy adults to characterize safety, tolerability, and pharmacokinetics/pharmacodynamics after single-ascending and multiple-ascending oral doses. A food-effect arm will compare drug absorption with and without a meal. Participants must meet age, weight, and BMI criteria and have no clinically significant medical problems or abnormal screening tests.
Why it matters
Potential benefit: If successful, SNH-119014 could become an oral PKR agonist option to reduce hemolysis and improve anemia in people with hemoglobinopathies.
How similar studies have gone: Other PKR activators (for example, mitapivat) have shown clinical benefit in some hemolytic anemias, so the mechanism has prior supporting evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The Second Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting
Study contacts
- Study coordinator: Wei Hu, Ph.D
- Email: huwei@ahmu.edu.com
- Phone: 86010-3856086475
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.