Human Mass Balance Study of [¹⁴C]HRS-1893
ConditionCardiomyopathies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
HRS-1893-107 is a Phase 1, single-center, non-randomized, open-label, single-dose study designed to investigate the mass balance, metabolism, and pharmacokinetics of \[14C\]HRS-1893. The study aims to quantify the radioactive recovery rate, determine the primary excretion pathways, evaluate the whole blood-to-plasma radioactivity ratio, identify major metabolites, and characterize the pharmacokinetic (PK) profile of HRS-1893 and its metabolites. Safety and tolerability will be monitored throughout the trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male.
Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg.
After comprehensive physical examinations (including vital signs, physical examinations, etc.) and laboratory tests (such as blood routine, blood biochemistry, coagulation function, urine routine, fecal routine + occult blood, thyroid function), as well as abdominal B-ultrasound and chest anteroposterior X-ray films, no clinically significant abnormalities were found (ALT, AST, total bilirubin, direct bilirubin, creatine kinase must be < 1.5 times the upper limit of the normal reference value, glomerular filtration rate (eGFR) > 90 mL/(min·1.73 m2)), or the researchers judged that there were minor abnormalities that did not affect the participants' enrollment (such as hemangioma, cyst, calcification focus, nodules, etc.). Among them, abdominal B-ultrasound and chest anteroposterior X-ray films can accept the abdominal B-ultrasound or abdominal CT that can be traced within 6 months before administration, and the results of chest anteroposterior X-ray films or chest CT.
The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be < 450 ms).
Disqualifiers
Systolic blood pressure (SBP) during the screening period or baseline period: SBP ≥ 140 mmHg or < 90 mmHg; Diastolic blood pressure (DBP): DBP ≥ 90 mmHg or < 60 mmHg, and the clinical doctor determines that it has clinical significance.
During the screening period, any one of the following infectious disease screenings - hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus antibody - showing any abnormal result and judged by the researcher to have clinical significance will be included.
There is a history of syncope in the past.
Those who have a history of allergies to drugs, foods, or the environment, or who are allergic to the test drug or any of its components.
Trial design
Design model
Single group
Treatments tested in this trial
[14C]HRS-1893
Drug\[14C\]HRS-1893 suspension.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: [14C]HRS-1893 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total radioactivity ratio of whole blood/plasma
Time frame
0 to anticipated 11 days.2
Time to reach maximum concentration (Tmax)
Time frame
0 to anticipated 11 days.3
Maximum concentration (Cmax)
Time frame
0 to anticipated 11 days.4
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
Time frame
0 to anticipated 11 days.Secondary outcomes
1
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
Time frame
0 to anticipated 11 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: