NCT07521345 A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
| NCT ID | NCT07521345 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Condition | Healhty |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2026-03-20 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female; 3. Body weight ≥50 kg for male subjects and ≥45 kg for female subjects at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m² (inclusive); 4. Subjects (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. Exclusion Criteria: 1. 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, 2. 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; 3. Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion; 4. abnormal HbA1c at screening; 5. Abnormal liver function test results 6. Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<90 mL/min/1.73 m² at screening; 7. Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function. 8. History of gastrointestinal diseases, with current symptoms of digestive discomfort ; 9. Current or past history of drug abuse, or a positive urine drug screen at screening; 10. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening; 11. Pregnant or breastfeeding females; 12. Subjects who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this study. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07521345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healhty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07521345 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07521345 currently recruiting?
Yes, NCT07521345 is actively recruiting participants. Contact the research team at chenmeixia@haisco.com for enrollment information.
Where is the NCT07521345 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07521345 clinical trial?
NCT07521345 is sponsored by Haisco Pharmaceutical Group Co., Ltd.. The trial plans to enroll 46 participants.