Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Healthy Adult Volunteers
Led by ScinnoHub Pharmaceutical Co., Ltd. · Updated on 2025-07-25
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying SNH-119014, an oral small-molecule drug that targets the pyruvate kinase red blood cell isozyme (PKR), to understand its safety, tolerability, and how the body absorbs and responds to it. This phase 1 trial involves healthy adult volunteers to gather initial information about the drug's effects and how food influences its absorption. The study involves giving participants either single ascending doses or multiple ascending doses of SNH-119014 or a placebo in a randomized, controlled manner. The treatment is administered orally, and the study uses a quadruple-masked design to compare effects without bias. Participants will undergo regular monitoring including physical examinations, vital signs checks, ECGs, and laboratory tests to detect any abnormal findings or adverse events related to the study drug. The primary outcome focuses on safety measures up to 7 or 20 days after dosing. The total participation duration and follow-up are designed to ensure thorough assessment of drug effects and safety in healthy adults aged 18 to 45 years.
CONDITIONS
Brief 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
- Aged 18 to 45 years, inclusive
- Male subjects weighing at least 50 kg, female subjects weighing at least 45 kg
- Body mass index (BMI) between 18.5 and 28.0 kg/m2
- Must provide written informed consent
You will not qualify if you...
- History or current presence of significant disorders affecting circulatory, endocrine, nervous, digestive, respiratory, urinary, eye, blood, immune, or psychiatric systems
- Major surgery within 6 months before screening or planned surgery during the study
- Clinically significant abnormal physical exam, vital signs, chest X-ray, or lab tests during screening
- QTcF greater than 450 ms or other significant ECG abnormalities
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV at screening
- Known chronic liver disease or abnormal liver function tests
- History of urinary system diseases
- History of swallowing difficulties or gastrointestinal disorders affecting drug absorption
- History of cancer
- History of severe allergies or hypersensitivity to the study drug or its components
- Failure to maintain a consistent diet
- Daily consumption of over 5 cups of caffeinated beverages in the 3 months before screening
- Consumption of certain foods or vigorous exercise within 48 hours before dosing affecting drug absorption
- Use of drugs altering liver enzymes within 28 days before screening
- Pregnant or lactating females or those unable to use non-pharmacological 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 3 months before screening or inability to comply with smoking ban
- Alcohol intake exceeding 14 units per week in the 6 months before screening or inability to comply with alcohol restriction
- History of drug abuse in the past year or positive drug test before randomization
- Plans to conceive or donate sperm or eggs during or within 3 months after the study
- Participation in another clinical study involving study drug within 3 months before dosing
- Blood donation or loss of 400 mL or more within 3 months before dosing or plans to donate during or within 3 months after the study
- Receipt of live attenuated vaccine within 28 days before dosing
- Intolerance to venipuncture or history of fainting related to needles or blood
- Investigator judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 days
Participants receive either the study drug SNH-119014 or a placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits during treatment period
Duration - Up to 7 days
Participants are monitored for adverse events and safety measures after treatment completion.
1 to 2 visits depending on safety assessments
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
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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