CompletedPhase 1

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

China6 participantsStarted 2024-09-03

Plain-language summary

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

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

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

Timeframe: 0-240 hours

Cumulative total radioactive recovery rate in urine and feces

Timeframe: 0-240 hours

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

Timeframe: 0-192 hours

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

Timeframe: 0-240 hours

Radioactivity Tmax

Timeframe: 0-192 hours

Radioactivity Cmax

Timeframe: 0-192 hours

Radioactivity AUC

Timeframe: 0-192 hours

Radioactivity t1/2

Timeframe: 0-192 hours

Trial details

NCT IDNCT06567392

SponsorChengdu Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Complement Mediated Primary or Secondary Glomerular Diseases trials

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

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

Timeframe: 0-240 hours

Cumulative total radioactive recovery rate in urine and feces

Timeframe: 0-240 hours

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

Timeframe: 0-192 hours

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

Timeframe: 0-240 hours

Radioactivity Tmax

Timeframe: 0-192 hours

Radioactivity Cmax

Timeframe: 0-192 hours

Radioactivity AUC

Timeframe: 0-192 hours

Radioactivity t1/2

Timeframe: 0-192 hours