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New treatment option for Hemoglobinopathy
Official title A Phase I Study of SNH-119014 in Healthy Volunteers
ClinicalTrials.gov ID: NCT07087262
What this study is testing
What is SNH-119014?
SNH-119014 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hemoglobinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male or female people;
- 18-45 years of age, inclusive;
- Male people with body weight ≥50 kg, female people with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.
- Must provide written informed consent.
You likely can't join if
- History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary...
- people 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...
- people 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...
- people who have a known chronic liver disease, or who have clinically significant abnormal liver function test results during the screening period;
See the full eligibility criteria
- Healthy male or female people;
- 18-45 years of age, inclusive;
- Male people with body weight ≥50 kg, female people with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.
- Must provide written informed consent.
- History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, ophthalmology, hematology, immunology, psychiatry disorder, as...
- people 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;
- people 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;
- people 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...
- people 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 people who are unable to use one or more nonpharmacological contraceptives.
- people 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.
- people 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...
- History of drug abuse in the past 1 year prior to screening, or a confirmed positive drugs of abuse test result before randomization.
- people who plan to conceive or donate sperm or eggs during the study or within 3 months after completion of study.
- people has received study drug in another clinical study within 3 months before the dose of study drug.
- people 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.
- people who have received a live attenuated vaccine within 28 days before the dose of study drug.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.