Healthy Male SubjectsPhase 1NCT05369858
A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
A Phase 1 study testing [14C] SKLB1028 in people with Healthy Male Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] SKLB1028. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- [14C] SKLB1028
- 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
- 6 Aug 2021to 11 Sep 2021
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Chinese male subjects aged 18 to 40 years (inclusive), with normal bowel movements (1~2 times a day).
- 2. A minimum body weight of 50 kg and a body mass index ranging from 19 to 26 kg/m^2 (inclusive).
- 3. The male subjects with fertility have no child rearing plan or sperm donation plan with their sexual partners during the trial and within one year after taking the drug, and could take reliable contraceptive measures.
- 4. Physical examination, vital signs, laboratory (blood routine, blood biochemistry, coagulation function, urine routine, stool routine and occult blood, etc.), 12 lead ECG, chest X-ray and other tests are normal or abnormal without clinical significance.
- 5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Who cannot join
- 1. Subjects with allergies or allergic diseases, or allergy to test preparations, any of their ingredients and food, or subjects with special dietary requirements, who can not follow the uniform diet.
- 2. Inability to swallow oral medications or presence of diseases that affect absorption, distribution, metabolism, or excretion of study medication, as well as the evaluation of drug efficacy and safety, such as hemorrhoids or perianal diseases with regular/ongoing stool blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.
- 3. History of gastrointestinal ulcer, bleeding, or clinically significant disease, including but not limited to circulatory, endocrine, nervous, digestive, urinary or blood, immune, mental, or metabolic diseases.
- 4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum antibody results within 1 month prior to dosing.
- 5. Use of any drug that inhibits or induces liver drug-metabolizing enzymes (inducers-barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine, glucocorticoid, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals, sedatives and hypnotics, fluoroquinolones, antihistamines, etc.) within 30 days prior to dosing.
- 6. Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication.
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- 7. Presence of major surgery or incomplete healing of surgical incision, including but not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, biopsy or significant traumatic injury within 6 months prior to dosing.
- 8. History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
- 9. Presence of alcohol abuse or regular use of alcohol within 6 months prior to dosing, i.e. weekly alcohol intake of more than 21 units (One unit is equivalent to 360 mL beer, 45 mL spirits containing 40% alcohol or 150 mL wine) or a positive urine or breath alcohol test at screening.
- 10. Smoking more than 10 cigarettes a day. 11. Presence or history of drug abuse or use of soft drugs (e.g. cannabis) within 3 months prior to dosing, or use of hard drugs (such as cocaine, amphetamine, phencyclidine, etc.) within the 3 months prior to dosing, or positive urine test for drugs of abuse at screening.
- 12. Habitual consumption of grapefruit juice or excessive drink (>8 cups per day, 1 cup =250 mL) containing caffeine, including coffee, tea.
- 13. Workers who need to be exposed to radioactive conditions for a long time; or have radiation exposure (more than 2 chest/abdominal CT, or more than 3 other types of X-ray examinations) within 1 year prior to dosing or participated in clinical studies of radiopharmaceuticals.
- 14. Blood loss or donation of one or more units of blood (400 mL) within 3 months prior to the first dose of study medication, or receive blood transfusion within 1 month.
- 15. Not suitable for this study as judged by the investigator for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] SKLB1028.
- Conditions
- Healthy Male Subjects
- Being tested
- [14C] SKLB1028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] SKLB1028Drug
A single 150 mg oral dose of [14C] SKLB1028 containing approximately 120 microcurie of [14C] SKLB1028
| Study group | Role | What they receive |
|---|---|---|
| [14C] SKLB1028 | Experimental | Eligible healthy male subjects received a single oral 150 mg (radioactivity of 120µCi) dose of [14C] SKLB1028 Receives: Drug: [14C] SKLB1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: From time zero up to 144 hours post-dose
Tmax
Time of maximum observed concentration
Measured: From time zero up to 144 hours post-dose
AUC0-t
Area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: From time zero up to 144 hours post-dose
AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity
Measured: From time zero up to 144 hours post-dose
Total radioactivity in urine and faces
Measured: From time zero up to 240 hours post-dose
Secondary outcomes (1)
Number of subjects with treatment-related adverse events
Measured: Up to approximately 14 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start6 Aug 2021
- Primary completion4 Sep 2021
- Study completion11 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369858
- Sponsor's protocol ID
- HA114-CSP-010
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05369858
- Acronym / sponsor ID
- HA114-CSP-010
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 11 Sep 2021 (actual)
- First posted
- 11 May 2022 (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.
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] SKLB1028.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] SKLB1028 | Experimental | Drug: [14C] SKLB1028Eligible healthy male subjects received a single oral 150 mg (radioactivity of 120µCi) dose of [14C] SKLB1028 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Chinese male subjects aged 18 to 40 years (inclusive), with normal bowel movements (1~2 times a day).
- 2. A minimum body weight of 50 kg and a body mass index ranging from 19 to 26 kg/m^2 (inclusive).
- 3. The male subjects with fertility have no child rearing plan or sperm donation plan with their sexual partners during the trial and within one year after taking the drug, and could take reliable contraceptive measures.
- 4. Physical examination, vital signs, laboratory (blood routine, blood biochemistry, coagulation function, urine routine, stool routine and occult blood, etc.), 12 lead ECG, chest X-ray and other tests are normal or abnormal without clinical significance.
- 5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Key exclusion criteria (14 listed)
- 1. Subjects with allergies or allergic diseases, or allergy to test preparations, any of their ingredients and food, or subjects with special dietary requirements, who can not follow the uniform diet.
- 2. Inability to swallow oral medications or presence of diseases that affect absorption, distribution, metabolism, or excretion of study medication, as well as the evaluation of drug efficacy and safety, such as hemorrhoids or perianal diseases with regular/ongoing stool blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.
- 3. History of gastrointestinal ulcer, bleeding, or clinically significant disease, including but not limited to circulatory, endocrine, nervous, digestive, urinary or blood, immune, mental, or metabolic diseases.
- 4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum antibody results within 1 month prior to dosing.
- 5. Use of any drug that inhibits or induces liver drug-metabolizing enzymes (inducers-barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine, glucocorticoid, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals, sedatives and hypnotics, fluoroquinolones, antihistamines, etc.) within 30 days prior to dosing.
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] SKLB1028A single 150 mg oral dose of [14C] SKLB1028 containing approximately 120 microcurie of [14C] SKLB1028 | Drug | [14C] SKLB1028 |
Primary outcome
Cmax
Time frame: From time zero up to 144 hours post-dose
Maximum observed plasma concentration
Tmax
Time frame: From time zero up to 144 hours post-dose
Time of maximum observed concentration
AUC0-t
Time frame: From time zero up to 144 hours post-dose
Area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-∞
Time frame: From time zero up to 144 hours post-dose
Area under the plasma concentration-time curve from time zero to infinity
Total radioactivity in urine and faces
Time frame: From time zero up to 240 hours post-dose
1 secondary outcome
Number of subjects with treatment-related adverse events
Time frame: Up to approximately 14 days after dosing
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 11 May 2022.
- Individual participant dataSharing planned: No
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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] SKLB1028 in people with Healthy Male Subjects, run by CSPC ZhongQi Pharmaceutical Technology 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 5 inclusion and 14 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 11 May 2022. 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?
Cmax (time frame: From time zero up to 144 hours post-dose). The study lists 5 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 11 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.