Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction
NCT ID: NCT06383897
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
116 participants
INTERVENTIONAL
2024-05-31
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort1：HS-10398
SAD： HS-10398 capsule
HS-10398
SAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14 IRF：HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction
Cohort2：HS-10398 Placebo
SAD：HS-10398 capsule placebo
HS-10398 Placebo
SAD：HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14
Cohort3：HS-10398
MAD： HS-10398 capsule
HS-10398
SAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14 IRF：HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction
Cohort4：HS-10398 Placebo
MAD：HS-10398 capsule placebo
HS-10398 Placebo
SAD：HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14
Cohort5：HS-10398
HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction
HS-10398
SAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14 IRF：HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction
Interventions
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HS-10398
SAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14 IRF：HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction
HS-10398 Placebo
SAD：HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1 MAD：HS-10398 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 14
Eligibility Criteria
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Inclusion Criteria
* Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
* Males' weight should be ≥ 50kg, and females' weight should be ≥ 45kg. Body mass index (BMI), calculated as weight/height\^2 (kg/m\^2), should be controlled within the range of 19 to 28, including the critical value
* Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration
* Participants with Kidney Dysfunction must have met the following additional criteria to be enrolled in this study：Patients with chronic kidney disease (defined as the presence of any markers of kidney damage or an estimated glomerular filtration rate (eGFR) persistently less than 90 mL/min/1.73m² for more than 3 months), and with an estimated glomerular filtration rate (eGFR) at screening and baseline assessments (with a minimum interval of 3 days between screening and baseline assessments) meeting the criteria of 60≤eGFR\<90 mL/min/1.73m².
Exclusion Criteria
* Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4/5 or CYP2C8 or any medications that inhibit P-glycoprotein transporters., within 2 weeks (or 5 half-lives) before screening and throughout the study period
* Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), \>450 ms (males), \>470 ms (females)
* Has participated in another clinical trial involving drugs or medical devices within the month prior to screening and received investigational drugs or used medical devices, or within 5 half-lives of the investigational drugs from another trial at the time of screening, whichever is longer
* Unable to abstain from smoking and alcohol.
* History of drug dependence or substance abuse
18 Years
64 Years
ALL
Yes
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Affiliated Hospital of Qingdao University
Qingdao, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-10398-101
Identifier Type: -
Identifier Source: org_study_id
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