A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects

Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study of Multiple Doses of HRS-5965 Capsules in Healthy Subjects and a Phase I Clinical Trial of the Effect of HRS-5965 on QT Interval in Healthy Subjects

This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.

Study Overview

• Status: Completed
• Conditions: Hemolytic Anemia
• Intervention / Treatment: Drug: HRS-5965 capsule; Drug: HRS-5965 capsule placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form before any activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict accordance with the clinical trial protocol.
2. Aged between 18 and 45 years old (based on the time of signing the informed consent form), both males and females are eligible.
3. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 26 kg/m².
4. During the screening period, there are no abnormalities in physical examination, vital signs, twelve - lead electrocardiogram, frontal and lateral chest radiographs, abdominal ultrasound, and laboratory tests, or those with minor abnormalities but judged by the investigator to be of no clinical significance.
5. During the screening period, human immunodeficiency virus antibody (HIV - Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV - Ab) are all negative.
6. Complete the vaccination of Neisseria meningitidis and Streptococcus pneumoniae vaccines 2 weeks before the first administration of HRS - 5965.

Exclusion Criteria:

1. The researcher has determined that there may be diseases or medical conditions that affect the absorption, distribution, metabolism and excretion of drugs or reduce compliance.
2. According to the judgment of the researcher, any physiological or psychological disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.
3. Those with a previous history of Neisseria meningitidis infection, or those whose first - degree relatives have a history of Neisseria meningitidis infection.
4. Those with definite evidence of infection within 2 weeks before screening (positive etiological examination, or having received systemic antibiotic treatment), or those who have had a body temperature exceeding 38 °C.
5. Subjects with abnormal serum electrolytes (hypokalemia, hypomagnesemia, hypocalcemia).
6. Subjects with a history of convulsive disorders, long QT syndrome (including family history), syncope while swimming or any other type of syncope or history of loss of consciousness.
7. Subjects with a previous history of heart disease, such as hypertension, atherosclerosis, heart failure, bradycardia or stroke, or those using a pacemaker.
8. Those with a serum creatinine level exceeding the upper limit of the normal value, or those whose level does not exceed the upper limit but are judged by the investigator to be at risk of renal function impairment.
9. Those with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal value (ULN), or with total bilirubin exceeding 1.5 times the ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1	Drug: HRS-5965 capsule; HRS-5965 capsule; Drug: HRS-5965 capsule placebo; HRS-5965 capsule placebo
Experimental: Dose 2	Drug: HRS-5965 capsule; HRS-5965 capsule; Drug: HRS-5965 capsule placebo; HRS-5965 capsule placebo
Experimental: Dose 3	Drug: HRS-5965 capsule; HRS-5965 capsule; Drug: HRS-5965 capsule placebo; HRS-5965 capsule placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subjects with adverse events (AEs)	Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation.	Baseline up to seven days after the last dosing.
QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules		Baseline up to 24 hours after dosing.

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for HRS-5965	Baseline up to seven days after the last dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for HRS-5965	Baseline up to seven days after the last dosing.
Maximum plasma concentration (Cmax) for HRS-5965	Baseline up to seven days after the last dosing.
Time to reach maximum plasma concentration (Tmax) for HRS-5965	Baseline up to seven days after the last dosing.
Terminal half-life (t1/2) for HRS-5965	Baseline up to seven days after the last dosing.
Apparent clearance (CL/F) of HRS-5965 for administration subcutaneously	Baseline up to seven days after the last dosing.
Apparent volume of distribution (V/F) of HRS-5965 for administration subcutaneously	Baseline up to seven days after the last dosing.
Complement system alternative pathway (AP) inhibition efficiency	Baseline up to seven days after the last dosing.

Collaborators and Investigators

• Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2024
• Primary Completion (Actual): April 7, 2025
• Study Completion (Actual): April 7, 2025

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Anemia, Hemolytic
• Other Study ID Numbers: HRS-5965-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No