NCT05942625 A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
| NCT ID | NCT05942625 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | IgA Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2024-06-30 |
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 84 participants in total. It began in 2023-05-23 with a primary completion date of 2024-06-30.
⚠ 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
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05942625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying IgA Nephropathy. 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 NCT05942625 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 NCT05942625 currently recruiting?
Yes, NCT05942625 is actively recruiting participants. Contact the research team at liubc64@163.com for enrollment information.
Where is the NCT05942625 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05942625 clinical trial?
NCT05942625 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 84 participants.