Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction

NCT06383897 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10398-101
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction

Conditions

Healthy

Keywords

HS-10398; Phase 1; Healthy

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs)

  The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  From screening to day 15

• Serious adverse events (SAEs)

  The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.

  From screening to day 15

Secondary Outcomes (5)

• Observed maximum plasma concentration (Cmax)

  up to 216 hours after dosing

• Time to reach maximum plasma concentration (Tmax)

  up to 216 hours after dosing

• Elimination Halflife (T1/2)

  up to 216 hours after dosing

• Apparent clearance（CL/F）

  up to 216 hours after dosing

• Apparent Volume of Distribution（Vd/F）

  up to 216 hours after dosing

Study Arms (5)

Cohort1：HS-10398

EXPERIMENTAL

SAD： HS-10398 capsule

Drug: HS-10398

Cohort2：HS-10398 Placebo

PLACEBO COMPARATOR

SAD：HS-10398 capsule placebo

Drug: HS-10398 Placebo

Cohort3：HS-10398

EXPERIMENTAL

MAD： HS-10398 capsule

Drug: HS-10398

Cohort4：HS-10398 Placebo

PLACEBO COMPARATOR

MAD：HS-10398 capsule placebo

Drug: HS-10398 Placebo

Cohort5：HS-10398

EXPERIMENTAL

HS-10398 capsule will be administered orally once on Day 1 in Participants With Kidney Dysfunction

Drug: HS-10398

Interventions

HS-10398 DRUG

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

Cohort1：HS-10398; Cohort3：HS-10398; Cohort5：HS-10398

HS-10398 Placebo DRUG

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

Cohort2：HS-10398 Placebo; Cohort4：HS-10398 Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged from 18 to 64 years
• 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.

You may not qualify if:

• Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
• 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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Central Study Contacts

Yu Cao, PhD

CONTACT

+86 18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: April 25, 2024
• Study Start: May 31, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)