A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers

NCT06567392 | Completed Phase 1

• 1 other identifier: HRS-5965-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the Mass Balance of \[14C\] HRS-5965 in Healthy Adult Volunteers.

Conditions

Complement Mediated Primary or Secondary Glomerular Diseases

Outcome Measures

Primary Outcomes (11)

• Total radioactive recovery rate in urine and feces at each time interval

  0-240 hours

• Cumulative total radioactive recovery rate in urine and feces

  0-240 hours

• 3. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)

  0-192 hours

• Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)

  0-240 hours

• Radioactivity Tmax

  0-192 hours

• Radioactivity Cmax

  0-192 hours

• Radioactivity AUC

  0-192 hours

• Radioactivity t1/2

  0-192 hours

• Radioactivity CL/F

  0-192 hours

• Radioactivity Vz/F

  0-192 hours

• Total radioactivity ratio for blood/plasma

  0-96 hours

Secondary Outcomes (8)

• Plasma HRS-5965: Tmax

  0-192 hours

• Plasma HRS-5965: Cmax

  0-192 hours

• Plasma HRS-5965: AUC

  0-192 hours

• Plasma HRS-5965: t1/2

  0-192 hours

• Plasma HRS-5965: CL/F

  0-192 hours

Study Arms (1)

[14C] HRS-5965

EXPERIMENTAL

Drug: [14C] HRS-5965

Interventions

[14C] HRS-5965 DRUG

Patients will receive single dose of orally \[14C\] HRS-5965 on Day 1.

[14C] HRS-5965

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content, and potential adverse reactions;
• Healthy adult males between 18 and 45 years;
• Body weight ≥50 kg, and the body mass index (BMI) of 19 to 26 kg/m2;
• From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.

You may not qualify if:

• Comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine analysis, fecal analysis, thyroid function), full chest anteroposterior and lateral film, abdominal ultrasound, and anoscope results that the researcher deems clinically significant.
• Patients with QTcF\>450 msec at the time of screening or baseline, or 12 lead electrocardiogram examination are abnormal and determined by the researcher to have clinical significance.
• Patients with clinically significant abnormalities in ophthalmic examinations (color vision, slit lamp, intraocular pressure, and fundus photography).
• Patients whose blood creatinine levels exceed the upper limit of normal values.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal values (ULN), or total bilirubin exceeding 1.5 times ULN.
• Hepatitis B surface antigen (HBsAg) positive, or anti hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or Treponema pallidum antibody positive.
• Abuse of drugs or use of soft drugs (such as marijuana) in the three months prior to screening, or use of hard drugs (such as amphetamines, phencyclidine, etc.) in the year prior to screening; Or screening period urine drug test positive individuals.
• Patients used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 4 weeks before screening; Or select those who are within 5 half-lives of the drug at the time of screening (whichever is longer).
• Patients who are allergic to two or more allergens, or who have been determined by the researcher to be potentially allergic to the investigational drug or its components 11. Any clinical history of serious diseases or conditions that the researcher believes may affect the trial results, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and metabolic diseases.
• According to the judgment of researchers, there may be diseases or medical conditions that may affect drug absorption, distribution, metabolism, and excretion, or may reduce compliance.
• Patients with combined diseases of the respiratory, circulatory, digestive, urinary, psychiatric, hematological, endocrine, metabolic, and immune systems.
• Patients with a history of meningococcal infection or first-degree relatives with a history of meningococcal infection.
• Screening for individuals with clear evidence of infection (positive pathogen test or previous systemic antibiotic treatment) or those with a body temperature above 38 ℃ within the first 2 weeks.
• Screening for individuals with severe trauma or surgery within the first 8 weeks, or those planning to undergo surgery during the trial period.
• Subjects with a history of recurrent oral ulcers.

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital Of Shandong First Medical University（Shandong Provincial Qianfoshan Hospital）

Jinan, Shandong, 250014, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single oral dose of \[14C\] HRS-5965

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: September 3, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)