Clinical trial NCT05942625: A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: IgA Nephropathy
Focal Segmental Glomerulosclerosis
Keywords: HS-10390
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
timeFrame: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Time to reach Cmax (Tmax)
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Half time (t½)
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Apparent clearance (CL/F)
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Apparent volume of distribution (Vz/F)
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Accumulation ratio（Rac）
timeFrame: Day 14 up to Day 19 (MAD)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Affiliated to Southeast University
state: Jiangsu
Study officials:
References: