Evaluating the safety and tolerability of HS-10390 in healthy individuals
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects
This study is testing a new medication called HS-10390 in healthy people to see if it's safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05942625 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HS-10390 in healthy subjects. It employs a randomized, double-blind, placebo-controlled design with both single and multiple ascending dose cohorts. The study will begin with a sentinel dosing strategy to ensure safety before proceeding to the multiple ascending dose phase. Participants will receive either HS-10390 or a placebo tablet during the trial.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18-45 who meet specific health criteria.
Not a fit: Patients with significant underlying health conditions or a history of infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of HS-10390's safety profile, paving the way for its use in treating conditions like IgA Nephropathy and Focal Segmental Glomerulosclerosis.
How similar studies have performed: While this is a first-in-human study for HS-10390, similar studies evaluating safety and tolerability of new drugs have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy male or female subjects between the ages of 18-45 years * Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing * Have signed the informed consent form approved by the IRB Exclusion Criteria: * History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator * Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis * Have a history of or current allergic disease * Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse * Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine * Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests * Pregnant or breastfeeding female subjects
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital, Affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Bicheng Liu
- Email: liubc64@163.com
- Phone: 18001580838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.