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Tests treatment safety and results for Healhty
Official title A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
ClinicalTrials.gov ID: NCT07521345
What this study is testing
What is HSK55879?
HSK55879 is an investigational medicine, being studied as a potential treatment for healhty.
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
- This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the...
- Healthy people aged 18 to 45 years (inclusive) at screening, male or female;
- Body weight ≥50 kg for male people and ≥45 kg for female people at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m²...
- people (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use...
You likely can't join if
- Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study...
- Physical examination, vital signs, laboratory tests，abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be...
- Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or...
- abnormal HbA1c at screening;
- Abnormal liver function test results
- Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<90 mL/min/1.73...
See the full eligibility criteria
- Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the written informed consent form prior to the start of the study;
- Healthy people aged 18 to 45 years (inclusive) at screening, male or female;
- Body weight ≥50 kg for male people and ≥45 kg for female people at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m² (inclusive);
- people (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use reliable contraceptive measures during this period.
- Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study drug,
- Physical examination, vital signs, laboratory tests，abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be clinically significant abnormalities;
- Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion;
- abnormal HbA1c at screening;
- Abnormal liver function test results
- Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<90 mL/min/1.73 m² at screening;
- Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function.
- History of gastrointestinal diseases, with current symptoms of digestive discomfort ;
- Current or past history of drug abuse, or a positive urine drug screen at screening;
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
- Pregnant or breastfeeding females;
- people who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this 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.