Complement Mediated Primary or Secondary Glomerular DiseasesPhase 1NCT06567392
A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers
A Phase 1 study testing [14C] HRS-5965 in people with Complement Mediated Primary or Secondary Glomerular Diseases, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complement Mediated Primary or Secondary Glomerular Diseases
- What is being tested?
- [14C] HRS-5965
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 8 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Perianal diseases with hemorrhoids or periodic/ongoing rectal bleeding; The subject is unable to swallow or has difficulty swallowing, or has a history of gastrointestinal dysfunction such as irritable bowel syndrome, inflammatory bowel disease, or has undergone surgery such as gastrectomy, which the researcher determines may affect drug absorption.
- Habitual constipation or diarrhea, irregular or difficult bowel movements, or other situations that have been evaluated by the researcher and affect the collection of fecal samples.
- Have a history of severe vomiting.
- Screening for individuals who smoke an average of 5 or more cigarettes per day within the first 4 weeks, or who are unable to quit nicotine containing products (including nicotine patches) during the trial period.
- The average daily intake of alcohol in the four weeks before screening exceeds 15 g (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine or 50 mL of low alcohol Baijiu), or the alcohol breath test is positive during screening, or the patient uses or drinks any food or drink containing alcohol within 48 hours before administration, or cannot quit during the test.
- Habitually drinking grapefruit or grapefruit juice or orange juice, or products containing caffeine or xanthine (such as coffee, tea, cola drinks, and chocolate), or using these products within 48 hours before administration, or unable to quit during the trial period.
- Clinical trials involving any other drug or medical device within the first 3 months of screening or planned to be conducted during the study period, or those who are still within 5 half-lives of the drug before screening (whichever is longer).
- Vaccines administered within 2 weeks prior to the first administration or planned during the study period and within 1 month after the last administration.
- Individuals with a history of blood donation or severe blood loss (blood loss ≥ 400 mL) within the 8 weeks prior to screening, or those who have received a blood transfusion within the 12 weeks prior to screening.
- Engaged in workers who require long-term exposure to radioactive conditions; Or select individuals who have had significant radiation exposure (chest/abdominal CT ≥ 2 times, or other types of X-ray examinations ≥ 3 times) or participated in radiopharmaceutical labeling trials within the previous year.
- Difficulty in venous blood collection or inability to withstand blood collection due to physical condition; Or subjects who are expected to be unable to complete the entire trial follow-up.
- The researcher determined that the subjects had other factors that were not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of Shandong First Medical University（Shandong Provincial Qianfoshan Hospital）
Jinan, Shandong, 250014
About this study
Official title: Phase I Clinical Trial of Mass Balance of [14C] HRS-5965 in Healthy Chinese Subjects
Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers.
- Being tested
- [14C] HRS-5965
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] HRS-5965Drug
Patients will receive single dose of orally [14C] HRS-5965 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| [14C] HRS-5965 | Experimental | Not described Receives: Drug: [14C] HRS-5965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactive recovery rate in urine and feces at each time interval
Measured: 0-240 hours
Cumulative total radioactive recovery rate in urine and feces
Measured: 0-240 hours
3. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Measured: 0-192 hours
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Measured: 0-240 hours
Radioactivity Tmax
Measured: 0-192 hours
Radioactivity Cmax
Measured: 0-192 hours
Radioactivity AUC
Measured: 0-192 hours
Radioactivity t1/2
Measured: 0-192 hours
Radioactivity CL/F
Measured: 0-192 hours
Radioactivity Vz/F
Measured: 0-192 hours
Total radioactivity ratio for blood/plasma
Measured: 0-96 hours
Secondary outcomes (8)
Plasma HRS-5965: Tmax
Measured: 0-192 hours
Plasma HRS-5965: Cmax
Measured: 0-192 hours
Plasma HRS-5965: AUC
Measured: 0-192 hours
Plasma HRS-5965: t1/2
Measured: 0-192 hours
Plasma HRS-5965: CL/F
Measured: 0-192 hours
Plasma HRS-5965: Vz/F
Measured: 0-192 hours
Plasma HRS-5965: λz
Measured: 0-192 hours
AEs and SAEs
Measured: 0-11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start3 Sep 2024
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complement Mediated Primary or Secondary Glomerular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single oral dose of \[14C\] HRS-5965
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567392
- Sponsor's protocol ID
- HRS-5965-105
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Mass Balance of [14C] HRS-5965 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06567392
- Acronym / sponsor ID
- HRS-5965-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single oral dose of [14C] HRS-5965
| Arm | Type | Receives |
|---|---|---|
| [14C] HRS-5965 | Experimental | Drug: [14C] HRS-5965 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] HRS-5965Patients will receive single dose of orally [14C] HRS-5965 on Day 1. | Drug | [14C] HRS-5965 |
Primary outcome
Total radioactive recovery rate in urine and feces at each time interval
Time frame: 0-240 hours
Cumulative total radioactive recovery rate in urine and feces
Time frame: 0-240 hours
3. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Time frame: 0-192 hours
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
Time frame: 0-240 hours
Radioactivity Tmax
Time frame: 0-192 hours
Radioactivity Cmax
Time frame: 0-192 hours
Radioactivity AUC
Time frame: 0-192 hours
Radioactivity t1/2
Time frame: 0-192 hours
Radioactivity CL/F
Time frame: 0-192 hours
Radioactivity Vz/F
Time frame: 0-192 hours
Total radioactivity ratio for blood/plasma
Time frame: 0-96 hours
8 secondary outcomes
Plasma HRS-5965: Tmax
Time frame: 0-192 hours
Plasma HRS-5965: Cmax
Time frame: 0-192 hours
Plasma HRS-5965: AUC
Time frame: 0-192 hours
Plasma HRS-5965: t1/2
Time frame: 0-192 hours
Plasma HRS-5965: CL/F
Time frame: 0-192 hours
Plasma HRS-5965: Vz/F
Time frame: 0-192 hours
Plasma HRS-5965: λz
Time frame: 0-192 hours
AEs and SAEs
Time frame: 0-11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] HRS-5965 in people with Complement Mediated Primary or Secondary Glomerular Diseases, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactive recovery rate in urine and feces at each time interval (time frame: 0-240 hours). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.