HealthyPhase 1NCT06224595
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles and Food Effect of CS32582 Capsules
A Phase 1 study testing CS32582 capsule in people with Healthy, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial summary
The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CS32582 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 27 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, both male and female.
- Between18 and 55 years of age (inclusive) at screening visit.
- BMI between 19.0-26.0 kg/m^2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
- Subject is medically healthy or judged by the investigator to be abnormal but clinically insignificant based on the results of history inquiry, physical examination, vital signs, standard 12-lead electrocardiogram, X-ray, abdominal ultrasound examination, and clinical laboratory tests at the time of screening visit.
- All subjects and female partners of male agree to use medically recognized effective methods of contraception (including physical contraception, surgical contraception, abstinence, etc.) from the start of signing informed consent form to 3 months after the last dose.
- Subjects voluntarily participate in the study and sign informed consent form.
Who cannot join
- History of clinically significant drug allergy or atopic allergic diseases (asthma, urticaria, eczematous dermatitis) or drug allergy to investigational products or similar investigational products.
- History of cardiovascular system, endocrine system, nervous system, respiratory system, digestive system, liver, kidney, blood and lymphatic system, immune system, psychiatric diseases and metabolic abnormalities.
- Conditions that may affect the determination of skin adverse events related to the investigational drug, including but not limited to sunburn, excessive tattooing (covering more than 25% of body surface area), or existing acne extending beyond sebum-prone areas (i.e., arms, torso, back, buttocks, and/or genital area).
- History of myalgia or rhabdomyolysis.
- History of hereditary hyperbilirubinemia.
- History of gastrointestinal, hepatic, or renal diseases or surgeries within the past 6 months that could affect drug absorption or metabolism, excluding uncomplicated appendectomy and hernia repair.
Show all 31Show fewer
- History of active tuberculosis or positive tuberculosis at the screening visit.
- History of recurrent bacterial, fungal, or viral infections (≥3 occurrences in the past year, excluding common cold), or active infection requiring treatment at the screening visit, or history of infection within ≤8 weeks before baseline visit requiring intravenous anti-infective drugs and/or hospitalization, or history of infection requiring oral anti-infective drugs ≤2 weeks before baseline visit.
- Untreated diarrhea at baseline visit or diarrhea symptoms within 7 days before the planned first dose.
- History of drug abuse.
- Vaccination within the past 3 months at the screening visit or plans for any vaccination during the study.
- Participation in an interventional clinical trial (device or drug) within the past 3 months or use of investigational drugs within the past 3 months or still within 5 half-life of that drug (whichever is longer) at the screening visit.
- Blood donation or significant blood loss (>300 mL) within the past 3 months at the screening visit.
- Use of any prescription drugs, non-prescription drugs, any vitamin products, or herbal products within the past month before baseline visit.
- Inability to tolerate venepuncture or history of needle or blood-related fainting.
- Regular alcohol consumption exceeding 7 drinks per week for females or 14 drinks per week for males in the past 3 months at the screening visit, or use of any alcohol-containing product within 48 hours before the planned first dose.
- Smoking more than 5 cigarettes or equivalent tobacco daily within the past 3 months at the screening visit or inability to quit smoking during the study.
- Consumption of excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups) daily within the past 14 days before baseline visit, or consumption of tea, coffee, and/or caffeine-containing beverages or foods within 48 hours before the planned first dose.
- Consumption of grapefruit or grapefruit-containing products within the past 14 days before baseline visit.
- Systolic blood pressure less than 90 mmHg or greater than 140 mmHg, and/or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg at screening and baseline visits.
- Glomerular filtration rate (eGFR) <90 mL/min (calculated using CKD-EPI equation with blood creatinine, age, and gender) at screening and baseline visits.
- QTcF ≥450 ms or other clinically significant abnormalities of standard 12-lead electrocardiogram judged by the investigator at screening and baseline visits.
- Meeting any of the following at screening and baseline visits: Blood routine: White blood cell count <3.5×10^9/L or neutrophil count <1.8×10^9/L or hemoglobin <115 g/L for females or <130 g/L for males; or platelet count <125×10^9/L. Blood creatinine above the upper limit of normal (ULN). Alanine aminotransferase or aspartate aminotransferase or total bilirubin or direct bilirubin above ULN.
- Inability to provide a negative human immunodeficiency virus (HIV) antibody report at screening visit.
- Positive results for syphilis serology, hepatitis B surface antigen (HBsAg), HBV-DNA quantification, or hepatitis C virus antibody (HCV-Ab) at screening and baseline visits.
- Positive urine drug abuse screening (opiates, methamphetamine, ketamine, ecstasy, marijuana, cocaine) or positive alcohol breath test at screening and baseline visits.
- Pregnant or lactating females, or females with serum human chorionic gonadotropin (HCG) ≥5 mIU/mL.
- Need or plan to engage in strenuous physical activity or exercise during the study.
- Participants unable to tolerate a high-fat meal (applicable only to participants in postprandial trials).
- Participants with swallowing difficulties.
- Other situations deemed unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles Following Single and Multiple Doses and Food Effect of CS32582 Capsules in Healthy Adult Subjects
The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.
Read the detailed description
This study consists of 3 parts: single ascending dose (SAD), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study is a randomized, open-label, two-period, two-crossover design.
- Conditions
- Healthy
- Being tested
- CS32582 capsule, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS32582 capsuleDrug
Participants receive CS32582 orally single or multiple doses
Placebo capsuleDrug
Participants receive placebo matching CS32582 orally single or multiple doses
| Study group | Role | What they receive |
|---|---|---|
| CS32582 Cohort 1 | Experimental | Subjects receive a single dose of 3 mg CS32582 or matching placebo Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 2 | Experimental | Subjects receive a single dose of 6 mg CS32582 or matching placebo Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 3 | Experimental | Subjects receive a single dose of 12 mg CS32582 or matching placebo Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 4 | Experimental | Subjects receive a single dose of 24 mg CS32582 or matching placebo Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 5 | Experimental | Subjects receive a single dose of 36 mg CS32582 or matching placebo Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 6 | Experimental | Subjects receive a single dose of 54 mg CS32582 or matching placebo Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 7 | Experimental | Subjects receive a single dose 12 mg CS32582 in either the fasted or fed state for two periods Receives: Drug: CS32582 capsule |
| CS32582 Cohort 8 | Experimental | Subjects receive 3 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 9 | Experimental | Subjects receive 6 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 10 | Experimental | Subjects receive 12 mg CS32582 or matching placebo for 10 days, once daily from Day 1 to Day 10. Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
| CS32582 Cohort 11 | Experimental | Subjects receive 12 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. Receives: Drug: CS32582 capsule; Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs)
To investigate the safety and tolerability by assessment of AEs following administration.
Measured: From the time of signing the informed consent form to 7 days after the last administration of the drug
Pharmacokinetic parameters - Area Under the Curve(AUC)
Area Under the Plasma Concentration-time Curve of CS32582.
Measured: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration of CS32582.
Measured: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Pharmacokinetic parameters - Time of Peak Concentration(Tmax)
Time to reach maximum observed plasma concentration of CS32582.
Measured: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Plasma Elimination Half-Life of CS32582.
Measured: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start28 Mar 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, 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
- Model description
- The study consists of 3 parts: single ascending dose (SAD), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are a randomized, double-blind, placebo-controlled dose-escalation design. The FE study is a randomized, open-label, two-period, two-crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224595
- Sponsor's protocol ID
- CS32582-101
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 3 Dec 2024
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles Following Single and Multiple Doses and Food Effect of CS32582 Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06224595
- Acronym / sponsor ID
- CS32582-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 25 Jan 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.
The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.
Detailed description
This study consists of 3 parts: single ascending dose (SAD), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study is a randomized, open-label, two-period, two-crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
- Model description
- The study consists of 3 parts: single ascending dose (SAD), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are a randomized, double-blind, placebo-controlled dose-escalation design. The FE study is a randomized, open-label, two-period, two-crossover design.
| Arm | Type | Receives |
|---|---|---|
| CS32582 Cohort 1 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive a single dose of 3 mg CS32582 or matching placebo |
| CS32582 Cohort 2 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive a single dose of 6 mg CS32582 or matching placebo |
| CS32582 Cohort 3 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive a single dose of 12 mg CS32582 or matching placebo |
| CS32582 Cohort 4 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive a single dose of 24 mg CS32582 or matching placebo |
| CS32582 Cohort 5 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive a single dose of 36 mg CS32582 or matching placebo |
| CS32582 Cohort 6 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive a single dose of 54 mg CS32582 or matching placebo |
| CS32582 Cohort 7 | Experimental | Drug: CS32582 capsuleSubjects receive a single dose 12 mg CS32582 in either the fasted or fed state for two periods |
| CS32582 Cohort 8 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive 3 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. |
| CS32582 Cohort 9 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive 6 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. |
| CS32582 Cohort 10 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive 12 mg CS32582 or matching placebo for 10 days, once daily from Day 1 to Day 10. |
| CS32582 Cohort 11 | Experimental | Drug: CS32582 capsule, Drug: Placebo capsuleSubjects receive 12 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy subjects, both male and female.
- Between18 and 55 years of age (inclusive) at screening visit.
- BMI between 19.0-26.0 kg/m^2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
- Subject is medically healthy or judged by the investigator to be abnormal but clinically insignificant based on the results of history inquiry, physical examination, vital signs, standard 12-lead electrocardiogram, X-ray, abdominal ultrasound examination, and clinical laboratory tests at the time of screening visit.
- All subjects and female partners of male agree to use medically recognized effective methods of contraception (including physical contraception, surgical contraception, abstinence, etc.) from the start of signing informed consent form to 3 months after the last dose.
Key exclusion criteria (31 listed)
- History of clinically significant drug allergy or atopic allergic diseases (asthma, urticaria, eczematous dermatitis) or drug allergy to investigational products or similar investigational products.
- History of cardiovascular system, endocrine system, nervous system, respiratory system, digestive system, liver, kidney, blood and lymphatic system, immune system, psychiatric diseases and metabolic abnormalities.
- Conditions that may affect the determination of skin adverse events related to the investigational drug, including but not limited to sunburn, excessive tattooing (covering more than 25% of body surface area), or existing acne extending beyond sebum-prone areas (i.e., arms, torso, back, buttocks, and/or genital area).
- History of myalgia or rhabdomyolysis.
- History of hereditary hyperbilirubinemia.
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 |
|---|---|---|
| CS32582 capsuleParticipants receive CS32582 orally single or multiple doses | Drug | CS32582 Cohort 1, CS32582 Cohort 10, CS32582 Cohort 11, CS32582 Cohort 2, CS32582 Cohort 3, CS32582 Cohort 4, CS32582 Cohort 5, CS32582 Cohort 6, CS32582 Cohort 7, CS32582 Cohort 8, CS32582 Cohort 9 |
| Placebo capsuleParticipants receive placebo matching CS32582 orally single or multiple doses | Drug | CS32582 Cohort 1, CS32582 Cohort 10, CS32582 Cohort 11, CS32582 Cohort 2, CS32582 Cohort 3, CS32582 Cohort 4, CS32582 Cohort 5, CS32582 Cohort 6, CS32582 Cohort 8, CS32582 Cohort 9 |
Primary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: From the time of signing the informed consent form to 7 days after the last administration of the drug
To investigate the safety and tolerability by assessment of AEs following administration.
Pharmacokinetic parameters - Area Under the Curve(AUC)
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Area Under the Plasma Concentration-time Curve of CS32582.
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Maximum Observed Plasma Concentration of CS32582.
Pharmacokinetic parameters - Time of Peak Concentration(Tmax)
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Time to reach maximum observed plasma concentration of CS32582.
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study.
Plasma Elimination Half-Life of CS32582.
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 3 Dec 2024.
- 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 CS32582 capsule in people with Healthy, run by Chipscreen Biosciences, 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 6 inclusion and 31 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 3 Dec 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?
Incidence and Severity of Adverse Events (AEs) (time frame: From the time of signing the informed consent form to 7 days after the last administration of the drug). 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 3 Dec 2024.