Phase 1 testing of oral SNH-119014 in healthy adults

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers

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
• Enrollment: 96 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: ScinnoHub Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07087262 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with existing hemoglobinopathies or other medical conditions are unlikely to receive therapeutic benefit from this healthy-volunteer Phase 1 study.

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 performed: Other PKR activators (for example, mitapivat) have shown clinical benefit in some hemolytic anemias, so the mechanism has prior supporting evidence.

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.

Where this trial is running

Hefei, Anhui

• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Wei Hu, Ph.D

Conditions Hemoglobinopathy