Clinical trials

Moderate Hepatic Impairment Study Phase This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase: Cohort A: Subjects with moderate hepatic impairment Cohort B: Subjects with normal hepatic function A total of 8 subjects of either gender will be enrolled in each cohort. Enrolled subjects will be admitted to the Phase I clinical research unit on Day -1 and fasted for at least 10 hours. On Day 1, subjects will receive a single oral dose of 20 mg HS-10506 tablets in a fasted state. Water intake is prohibited within 1 hour before and after dosing (excluding water used for drug administration). Food intake is restricted for at least 4 hours post-dose. All study medications will be administered with approximately 240 mL of water. Subjects with normal hepatic function (Cohort B) serve as the matched control group for subjects with moderate hepatic impairment (Cohort A), and shall meet the following matching criteria: The mean body mass index (BMI) of Cohort B is within ±10% of the mean BMI of Cohort A. The mean age of Cohort B is within ±3 years of the mean age of Cohort A. The number of male and female subjects in Cohort B is consistent with that in Cohort A for each gender. Mild Hepatic Impairment Study Phase Based on the results of the moderate hepatic impairment study phase, the sponsor and principal investigator will jointly determine whether to conduct a study to evaluate the effect of mild hepatic impairment. The phase design and procedures of the mild hepatic impairment are consistent with those of the moderate hepatic impairment. Subjects with normal hepatic function (Cohort D) serve as the matched control group for subjects with mild hepatic impairment (Cohort C), and shall meet the following matching criteria: The mean BMI of Cohort D is within ±10% of the mean BMI of Cohort C. The mean age of Cohort D is within ±3 years of the mean age of Cohort C. The number of male and female subjects in Cohort D is consistent with that in Cohort C for each gender.

This is a two-part single-center, open-label, parallel, single-dose pharmacokinetic study of HS-10504 in participants with hepatic impairment and normal hepatic function.

This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.

HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10582 following single and multiple dose administration to healthy subjects and subjects with Mildly Elevated LDL-C. This study will consist of two parts: single ascending dose (SAD) and multiple ascending dose (MAD).

This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.

This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\] HS-10504 in healthy adult male subjects.

This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.

The primary objective of this study is to evaluate the efficacy of HS-20118 compared with placebo in participants with moderate to severe plaque psoriasis.

The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse events leading to study drug discontinuationin Chinese adult participants with schizophrenia.

This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR C797S mutation after failure of EGFR TKI therapy.

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.

This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.

The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.

This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.

This is a multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.

The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.

This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.

The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and \<90 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and \< 3000 mg/g

A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.

This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.

This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study will evaluate the safety and tolerability of HS-20152, an investigational therapy targeting the complement pathway, in healthy adults. Secondary objectives include characterization of pharmacokinetics and pharmacodynamic effects on complement-related biomarkers.

This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.