Clinical Trials/NCT06039254

NCT06039254

Not yet recruiting

Phase 1

A Multicenter, Non-randomized, Open-label, Parallel-controlled Study to Evaluate the Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function

Shandong Suncadia Medicine Co., Ltd.0 sites27 target enrollmentSeptember 2023

ConditionsChronic Kidney Disease

InterventionsHRS-1780

DrugsHRS-1780

Overview

Phase: Phase 1
Intervention: HRS-1780
Conditions: Chronic Kidney Disease
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 27
Primary Endpoint: Pharmacokinetics-Cmax
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.

Registry

clinicaltrials.gov

Start Date

September 2023

End Date

December 8, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects：
•Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
•Male and female, 18 to 70 years of age, inclusive;
•Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
•Normal glomerular filtration rate;
•No clinically significant abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
•Men and WOCBP must agree to take highly effective contraceptive methods detailed in the protocol, have no plan to have a child from signing the consent form until at least one month after IP administration, and must not undertake for sperm/egg donation. Female participants should not be lactating.
•Renal impairment subjects：
•Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
•Male and female, 18 to 70 years of age, inclusive;

Exclusion Criteria

•Healthy subjects：
•Known history or suspected of being allergic to study drug or any component of it, or significant allergic reactions to other biologic products and drugs, or severe food allergies;
•Clinically significant abnormalities in 12-Lead ECG;
•Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plans to have surgeries during the study;
•Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, whichever is longer prior to screening, or plans to participate in another clinical study during this study;
•Use of any prescription medicine, over-the-counter medicine, herbal remedy, or nutritional supplement within 2 weeks prior to screening;
•Consumption of more than 14 units of alcohol per week within 6 months prior to screening, or incapable to refrain from consuming alcohol during the study, or positive alcohol breath test result;
•Consumption of more than 5 cigarettes daily (or products with an equivalent amount of nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours prior to dosing;
•History of illicit or prescription drug abuse or addiction in the past 5 years, or illicit or prescription drug abuse within 3 months prior to screening, or positive urine drug screen;
•Unwilling or unable to comply with the contraceptive methods detailed in this protocol;

Arms & Interventions

Healthy subjects group

Intervention: HRS-1780

Mild renal impairment group

Intervention: HRS-1780

Moderate renal impairment group

Intervention: HRS-1780

Outcomes

Primary Outcomes

Pharmacokinetics-Cmax

Time Frame: Start of Treatment to end of study (approximately 1 week)

Maximum observed concentration of HRS-1780

Pharmacokinetics-AUC0-last

Time Frame: Start of Treatment to end of study (approximately 1 week)

Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration

Pharmacokinetics-AUC0-inf

Time Frame: Start of Treatment to end of study (approximately 1 week)

Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration

Secondary Outcomes

Pharmacokinetics-t1/2(Start of Treatment to end of study (approximately 1 week）)
Pharmacokinetics-Cumulative excretion rate (Ae%)(Start of Treatment to end of study (approximately 1 week))
Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 1 week))
Pharmacokinetics-CL/F(Start of Treatment to end of study (approximately 1 week))
Adverse events(Start of Treatment to end of study (approximately 1 week))
Pharmacokinetics-Vz/F(Start of Treatment to end of study (approximately 1 week))
Pharmacokinetics-Renal clearance (CLr)(Start of Treatment to end of study (approximately 1 week))
Pharmacokinetics-Cumulative excretion (Ae)(Start of Treatment to end of study (approximately 1 week))
Binding rates of plasma protein (BRPP) of HRS-1780(Start of Treatment to end of study (approximately 1 week))