Healthy SubjectsPhase 1NCT05109663
A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects
A Phase 1 study testing SKLB1028 in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study was to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of SKLB1028 in healthy subjects. This study has also explored the effect of food on the PK of SKLB1028. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SKLB1028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2021to 30 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- Healthy subjects:
- Male or female subjects aged 18 to 45 (including 18 and 45 years old), and the proportion of single sex should not be less than 1/3;
- Male weight ≥50.0 kg, female weight ≥45.0 kg; body mass index (BMI) 18-24 kg/m^2 (inclusive);
- Normal or abnormal results without clinically significance on all tests including medical history, physical examination, vital signs, clinical laboratory tests (routine blood test, blood biochemistry, routine urine test, coagulation function), etc;
- Subjects are willing to use effective non-hormonal contraceptives such as condom and intrauterine device without medication, and not allowed to donate sperm from screening to the 6 months after the last dose administration unless permanent contraception has been taken, such as bilateral tubal ligation and vasectomy;
- Voluntarily sign the informed consent form, and be willing to comply with the protocol.
Who cannot join
- Previous or current clear psychiatric/neurological systems diseases; previous or current severe diseases, such as cardiovascular, liver and kidney, endocrine, respiratory, hematological, digestive and immune systems diseases; previous or current malignant tumors;
- Allergic constitution, including a history of allergy to one or more medications, or other known severe allergic reactions;
- Inability to swallow oral medications; previous or current diseases that may affect the absorption, distribution, metabolism, or excretion of the drug, or affect the evaluation of efficacy and safety of the drug, such as active bowel disease, partial or complete bowel obstruction and chronic diarrhea;
- Previous or current diseases such as gastrointestinal ulcer and related bleeding;
- Abnormalities of clinical significance in electrocardiogram (such as QTcF≥450 ms in males or ≥470 ms in females) or history of prolonged QTcF interval;
- Any abnormalities of clinical significance in vital signs;
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- Any positive test result of hepatitis B surface antigen or hepatitis C virus antibody, or anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
- Use of any prescription drugs, over-the-counter drugs, biologicals, proprietary Chinese medicine, herbal medicine, dietary supplements, health products, long-acting oral contraceptives or implantable long-acting contraceptives within 2 weeks prior to screening;
- Use of any strong inhibitors or inducers of CYP3A4, CYP2C8 or P-gp within 2 weeks prior to screening;
- Average daily intake of alcohol more than 14 units (14 units ≈285 mL of beer, or 25 mL of liquor, or 150 mL of wine) within 4 weeks prior to signature of informed consent, or a positive ethanol breath test at screening;
- Smoking more than 5 cigarettes per day within 6 months prior to screening;
- History of drug abuse within 1 year prior to screening, or positive urine drug screen at screening;
- Average daily consumption of too much caffeinated beverages and foods or that might affect drug metabolism, such as coffee (over 1100 mL per day), tea (over 2200 mL per day), cola (over 2200 mL per day), functional beverage (over 1100 mL per day), chocolate (over 510 g per day) within 4 weeks prior to screening;
- Consumption of cigarettes, alcohol or methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 h before the administration, or those who have special dietary requirements and cannot follow a uniform diet;
- Difficulty in venous blood collection or subjects with a history of fainting needle or blood;
- Blood donation (or blood loss) ≥200 mL within 4 weeks prior to the screening, or who have a blood donation plan during the entire study or within 1 months after the study;
- Subjects who have previously undergone surgery within 6 months prior to screening or who have a scheduled surgical plan (including cosmetic surgery, dental surgery and oral surgery) during the study period;
- Participation in another clinical trial within 3 months before screening (whichever is administrated);
- Any condition that the investigator considers inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Single-Administration, Dose-Escalation Study and A Single-Centre, Randomized, Open-Label, Two-cycle Crossover Food Effect Study of SKLB1028 in Healthy Subjects
The purpose of this study was to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of SKLB1028 in healthy subjects. This study has also explored the effect of food on the PK of SKLB1028.
Read the detailed description
The study was divided into 2 parts. Part 1(Dose Escalation) included 2 cohorts (Cohort 1 and Cohort 2) and subjects received a single oral dose of SKLB1028 50 or 100 mg on Day 1. In Part 2 (Food Effect) included 2 cohorts (Cohort A and Cohort B), subjects received a single oral dose of SKLB1028 150 mg in a fasting and a fed state, with a 10-day washout period between the 2 doses.
- Conditions
- Healthy Subjects
- Being tested
- SKLB1028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKLB1028Drug
SKLB1028, capsule, oral
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1: single oral dose of SKLB1028 | Experimental | Eligible subjects received a single dose of SKLB1028 50 mg on Day 1. Receives: Drug: SKLB1028 |
| Dose Escalation Cohort 2: single oral dose of SKLB1028 | Experimental | Eligible subjects received a single dose of SKLB1028 100 mg on Day 1. Receives: Drug: SKLB1028 |
| Food Effect Cohort A: SKLB1028, fasted dosing followed by fed dosing | Experimental | Eligible subjects received a single dose of SKLB1028 150 mg on Day 1 in a fasting state, and a single dose of SKLB1028 150 mg on Day 11 in a fed state, with a 10-day washout period between the 2 doses. Receives: Drug: SKLB1028 |
| Food Effect Cohort B: SKLB1028, fed dosing followed by fasted dosing | Experimental | Eligible subjects received a single dose of SKLB1028 150 mg on Day 4 in a fed state, and a single dose of SKLB1028 150 mg on Day 14 in a fasting state, with a 10-day washout period between the 2 doses. Receives: Drug: SKLB1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (TEAEs)
TEAEs were assessed by CTCAE v5.0 in Part 1
Measured: Throughout the study period, with an average of 10 days.
Maximum plasma concentration (Cmax) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to infinity (AUCinf) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Time to Cmax (Tmax) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Terminal-elimination half-life (T1/2) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent volume of distribution (Vz/F) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent clearance (CLz/F) of SKLB1028 in Part 2
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Secondary outcomes (8)
Maximum plasma concentration ( Cmax) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to infinity (AUCinf) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Time to Cmax (Tmax) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Terminal-elimination half-life (T1/2) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent volume of distribution (Vz/F) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent Clearance (CLz/F) of SKLB1028 in Part 1
Measured: Pre-dose and multiple timepoints up to 144 hours post-dose
Number of participants with TEAEs
TEAEs were assessed by CTCAE v5.0 in Part 2
Measured: Throughout the study period, with an average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start14 Apr 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT05109663
- Sponsor's protocol ID
- HA114-CSP-006
- Status last verified
- Jan 2021
- First submitted
- 27 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Single-Administration, Dose-Escalation Study and A Single-Centre, Randomized, Open-Label, Two-cycle Crossover Food Effect Study of SKLB1028 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05109663
- Acronym / sponsor ID
- HA114-CSP-006
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Nov 2021 (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.
The purpose of this study was to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of SKLB1028 in healthy subjects. This study has also explored the effect of food on the PK of SKLB1028.
Detailed description
The study was divided into 2 parts. Part 1(Dose Escalation) included 2 cohorts (Cohort 1 and Cohort 2) and subjects received a single oral dose of SKLB1028 50 or 100 mg on Day 1. In Part 2 (Food Effect) included 2 cohorts (Cohort A and Cohort B), subjects received a single oral dose of SKLB1028 150 mg in a fasting and a fed state, with a 10-day washout period between the 2 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort 1: single oral dose of SKLB1028 | Experimental | Drug: SKLB1028Eligible subjects received a single dose of SKLB1028 50 mg on Day 1. |
| Dose Escalation Cohort 2: single oral dose of SKLB1028 | Experimental | Drug: SKLB1028Eligible subjects received a single dose of SKLB1028 100 mg on Day 1. |
| Food Effect Cohort A: SKLB1028, fasted dosing followed by fed dosing | Experimental | Drug: SKLB1028Eligible subjects received a single dose of SKLB1028 150 mg on Day 1 in a fasting state, and a single dose of SKLB1028 150 mg on Day 11 in a fed state, with a 10-day washout period between the 2 doses. |
| Food Effect Cohort B: SKLB1028, fed dosing followed by fasted dosing | Experimental | Drug: SKLB1028Eligible subjects received a single dose of SKLB1028 150 mg on Day 4 in a fed state, and a single dose of SKLB1028 150 mg on Day 14 in a fasting state, with a 10-day washout period between the 2 doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- -
- Male or female subjects aged 18 to 45 (including 18 and 45 years old), and the proportion of single sex should not be less than 1/3;
- Male weight ≥50.0 kg, female weight ≥45.0 kg; body mass index (BMI) 18-24 kg/m^2 (inclusive);
- Normal or abnormal results without clinically significance on all tests including medical history, physical examination, vital signs, clinical laboratory tests (routine blood test, blood biochemistry, routine urine test, coagulation function), etc;
- Subjects are willing to use effective non-hormonal contraceptives such as condom and intrauterine device without medication, and not allowed to donate sperm from screening to the 6 months after the last dose administration unless permanent contraception has been taken, such as bilateral tubal ligation and vasectomy;
Key exclusion criteria (19 listed)
- Previous or current clear psychiatric/neurological systems diseases; previous or current severe diseases, such as cardiovascular, liver and kidney, endocrine, respiratory, hematological, digestive and immune systems diseases; previous or current malignant tumors;
- Allergic constitution, including a history of allergy to one or more medications, or other known severe allergic reactions;
- Inability to swallow oral medications; previous or current diseases that may affect the absorption, distribution, metabolism, or excretion of the drug, or affect the evaluation of efficacy and safety of the drug, such as active bowel disease, partial or complete bowel obstruction and chronic diarrhea;
- Previous or current diseases such as gastrointestinal ulcer and related bleeding;
- Abnormalities of clinical significance in electrocardiogram (such as QTcF≥450 ms in males or ≥470 ms in females) or history of prolonged QTcF interval;
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 |
|---|---|---|
| SKLB1028SKLB1028, capsule, oral | Drug | Dose Escalation Cohort 1: single oral dose of SKLB1028, Dose Escalation Cohort 2: single oral dose of SKLB1028, Food Effect Cohort A: SKLB1028, fasted dosing followed by fed dosing, Food Effect Cohort B: SKLB1028, fed dosing followed by fasted dosing |
Primary outcome
Number of participants with treatment-related adverse events (TEAEs)
Time frame: Throughout the study period, with an average of 10 days.
TEAEs were assessed by CTCAE v5.0 in Part 1
Maximum plasma concentration (Cmax) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to infinity (AUCinf) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Time to Cmax (Tmax) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Terminal-elimination half-life (T1/2) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent volume of distribution (Vz/F) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent clearance (CLz/F) of SKLB1028 in Part 2
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
8 secondary outcomes
Maximum plasma concentration ( Cmax) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Area under the concentration-time curve from time 0 to infinity (AUCinf) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Time to Cmax (Tmax) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Terminal-elimination half-life (T1/2) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent volume of distribution (Vz/F) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Apparent Clearance (CLz/F) of SKLB1028 in Part 1
Time frame: Pre-dose and multiple timepoints up to 144 hours post-dose
Number of participants with TEAEs
Time frame: Throughout the study period, with an average of 20 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 17 Nov 2021.
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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 SKLB1028 in people with Healthy 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 7 inclusion and 19 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 17 Nov 2021. 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?
Number of participants with treatment-related adverse events (TEAEs) (time frame: Throughout the study period, with an average of 10 days.). The study lists 8 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 17 Nov 2021.