Actively Recruiting
A Phase I Study of SNH-119014 in Healthy Volunteers
Led by ScinnoHub Pharmaceutical Co., Ltd. · Updated on 2025-07-25
96
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Study of SNH-119014 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female subjects
- Age between 18 and 45 years, inclusive
- Male subjects weighing at least 50 kg, female subjects weighing at least 45 kg
- Body mass index between 18.5 and 28.0 kg/m2
- Must provide written informed consent
You will not qualify if you...
- History of or current significant disorders in circulatory, endocrine, nervous, digestive, respiratory, urinary, eye, blood, immune, or psychiatric systems
- Major surgery within 6 months prior to screening or planned surgery during the study
- Significant abnormal physical exam, vital signs, chest X-ray, or lab tests during screening
- QTcF greater than 450 ms or other significant ECG abnormalities during screening
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV at screening
- Known chronic liver disease or abnormal liver function test results
- History of urinary system diseases
- History of swallowing difficulties or gastrointestinal disorders affecting drug absorption
- History of cancer
- Severe allergies or hypersensitivity to the study drug or its components
- Failure to follow a consistent diet
- Consumption of more than 5 cups of tea, coffee, or caffeinated drinks daily in the past 3 months
- Consumption of grapefruit, chocolate, caffeine-containing foods, or vigorous exercise within 48 hours before dosing
- Use of drugs affecting liver enzymes or transporters within 28 days prior to screening
- Pregnancy, lactation, or inability to use non-drug contraception
- Use of prescribed or over-the-counter drugs, herbal remedies, or nutraceuticals within 14 days before dosing
- Smoking more than 5 cigarettes per day in the past 3 months or inability to follow smoking ban during the study
- Alcohol intake over 14 units per week in the past 6 months or inability to follow alcohol ban during the study
- History of drug abuse in the past year or positive drug abuse test before randomization
- Planning to conceive or donate sperm or eggs during or within 3 months after the study
- Participation in another clinical study with study drug within 3 months before dosing
- Blood donation or loss of 400 mL or more within 3 months before dosing, or planning to donate blood during or within 3 months after the study
- Receipt of live attenuated vaccine within 28 days before dosing
- Inability to tolerate venipuncture or history of fainting during blood drawing
- Any condition judged by the investigator to make the subject unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
Research Team
W
Wei Hu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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