A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942625
• Other study ID #: HS-10390-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 23, 2023
• Est. completion date: February 16, 2024

Study information

• Verified date: July 2023
• Source: Hansoh BioMedical R&D Company
• Contact: Bicheng Liu
• Phone: 18001580838
• Email: liubc64[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• Glomerulonephritis, IGA
• Glomerulosclerosis, Focal Segmental
• IgA Nephropathy

Intervention

Drug:
• HS-10390 tablet
Oral administration of specified dose of HS-10390
• Placebo tablet
Oral administration of matching dose ofplacebo

Locations

Country	Name	City	State
China	Zhongda Hospital, Affiliated to Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Hansoh BioMedical R&D Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation		Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
Secondary	Maximum plasma concentration (Cmax)		Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Time to reach Cmax (Tmax)		Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Area under the plasma concentration-time curve from time zero to time t (AUC0-t)		Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Half time (t½)		Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Apparent clearance (CL/F)		Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Apparent volume of distribution (Vz/F)		Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Accumulation ratio(Rac)		Day 14 up to Day 19 (MAD)