Clinical trial NCT06684041: A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hemolytic Anemia
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of subjects with adverse events (AEs)
timeFrame: Baseline up to seven days after the last dosing.
measure: QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules
timeFrame: Baseline up to 24 hours after dosing.
Secondary outcomes:
measure: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for HRS-5965
timeFrame: Baseline up to seven days after the last dosing.
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for HRS-5965
timeFrame: Baseline up to seven days after the last dosing.
measure: Maximum plasma concentration (Cmax) for HRS-5965
timeFrame: Baseline up to seven days after the last dosing.
measure: Time to reach maximum plasma concentration (Tmax) for HRS-5965
timeFrame: Baseline up to seven days after the last dosing.
measure: Terminal half-life (t1/2) for HRS-5965
timeFrame: Baseline up to seven days after the last dosing.
measure: Apparent clearance (CL/F) of HRS-5965 for administration subcutaneously
timeFrame: Baseline up to seven days after the last dosing.
measure: Apparent volume of distribution (V/F) of HRS-5965 for administration subcutaneously
timeFrame: Baseline up to seven days after the last dosing.
measure: Complement system alternative pathway (AP) inhibition efficiency
timeFrame: Baseline up to seven days after the last dosing.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan hospital of Wuhan University
state: Hubei
Study officials:
References: