HealthyPhase 1NCT05922709
A Clinical Trial of CS12192 in Healthy Subjects
A Phase 1 study testing CS12192 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 CS12192 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 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CS12192 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 1 Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, both male and female.
- Between18 and 45 years of age (inclusive) at screening visit.
- BMI between 19.0-26.0 kg/m2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
- All subjects and female partners of male agree to use medically recognized effective contraceptive measures (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 disease or lung, hematological, immunological, psychiatric diseases and metabolic abnormalities.
- History or surgical history of gastrointestinal, hepatic, or renal disease that can affect drug absorption or metabolism within 6 months prior to the screening visit (except uncomplicated appendectomy and hernia repair).
- History of active tuberculosis, or positive tuberculosis screening at screening visit.
- History of any recurrent bacterial, fungal or viral infections (≥3 attacks in the past year, except the common cold), or active infections requiring treatment at screening visit, or history of infection requiring intravenous anti-infective drugs or hospitalization ≤8 weeks before randomization, or history of infection requiring oral anti-infective drugs ≤2 weeks before randomization.
- Uncured diarrhea before randomization, or history of diarrhea within 7 days before planning dosing.
Show all 26Show fewer
- Use of any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines within 1 month before randomization.
- History of drug abuse.
- Inability to tolerate venipuncture, or history of fainting or halo.
- Participation in interventional clinical study (device or drug) within 3 months prior to randomization, or taking investigational product within 3 months prior to randomization , or remaining within 5 half-lives of drug, whichever is longer.
- Blood donation or significant blood loss (>300 mL) within 3 months prior to randomization.
- Pregnant or lactating females, or female subjects with serum pregnancy test human chorionic gonadotropin (HCG) ≥5 mIU/mL.
- History of regular alcohol consumption, drinking more than 7 cups per week for females or 14 cups per week for males (1 cup= 100 mL wine = 285 mL beer = 25 mL spirits) within 3 months before randomization; or taking any products containing alcohol within 48 hours before the first dose; or having a positive alcohol breath test before randomization.
- Smoking more than 5 cigarettes or equivalent per day within 3 months prior to randomization or inability to refrain from smoking during the trail.
- Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups) per day within 14 days before randomization, or tea, coffee, caffeinated beverages or foods within 48 hours before randomization.
- Consumption of grapefruit or beverages or foods containing its ingredients within 14 days before randomization.
- Glomerular filtration rate (eGFR) <80 mL/min at screening visit and baseline visit (calculating by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for serum creatinine, age, and sex).
- Abnormal results in medical history inquiry, vital signs, physical examination, chest X-ray, and clinical laboratory tests are clinically significant.
- QTcF≥450 ms or other clinically significant abnormality as judging by the investigator on 12-lead ECG at screening visit and baseline visit.
- Human immunodeficiency virus antibody (HIV) cannot provide negative reports at screening visit.
- Syphilis serology, hepatitis B virus surface antigen (HBsAg), hepatitis B virus-DNA quantification, or hepatitis C virus antibody (HCV-Ab) positive at screening visit.
- Positive urine drug screening (morphine, methamphetamine, ketamine, ecstasy, marijuana, cocaine) before randomization.
- Need or plan to engage in strenuous physical activity or exercise during the study.
- Inability to tolerate high-fat and high-fever meal (only for fed study).
- Subjects with dysphagia.
- Other conditions considered inappropriate for participation in the study 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 CS12192 Capsules in Healthy Adult Chinese Subjects
The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS12192 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), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study use a randomized, open-label, two-period, two-crossover design.
- Conditions
- Healthy
- Being tested
- CS12192 capsule, Placebo capsule
- Keywords
- healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS12192 capsuleDrug
Participants receive CS12192 orally single or multiple doses
Placebo capsuleDrug
Participants receive placebo matching CS12192 orally single or multiple doses
| Study group | Role | What they receive |
|---|---|---|
| CS12192 Cohort 1 | Experimental | Subjects receive a single dose of 50 mg CS12192 or matching placebo. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 2 | Experimental | Subjects receive a single dose of 150 mg CS12192 or matching placebo. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 3 | Experimental | Subjects receive a single dose of 200 mg CS12192 or matching placebo. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 4 | Experimental | Subjects receive a single dose of 300 mg CS12192 or matching placebo. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 5 | Experimental | Subjects receive a single dose of 400 mg CS12192 or matching placebo. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 6 | Experimental | Subjects receive 200 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 7 | Experimental | Subjects receive 300 mg CS12192 or matching placebo, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 8 | Experimental | Subjects receive 400 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
| CS12192 Cohort 9 | Experimental | Subjects receive a single dose 400 mg CS12192 in either the fasted or fed state for two periods. Receives: Drug: CS12192 capsule |
| CS12192 Cohort 10 | Experimental | Subjects receive a single dose of 600 mg CS12192 or matching placebo. Receives: Drug: CS12192 capsule; Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Number of Adverse Events (AEs)
To investigate the safety and tolerability by assesment of AEs following administration.
Measured: up to 14 days
Pharmacokinetic parameters - Area Under the Curve(AUC)
Area Under the Plasma Concentration-time Curve of CS12192.
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 the last dose for food effect study.
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration of CS12192.
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 the last dose for food effect study.
Pharmacokinetic parameters - Time of peak concentration(Tmax)
Time to reach maximum observed plasma concentration of CS12192.
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 the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Plasma Elimination Half-Life of CS12192.
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 the last dose for food effect study. From time 0 to 48 hours after the last dose 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 posted28 Jun 2023
- Study start20 Jul 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 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), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study use a randomized, double-blind, placebo-controlled dose-escalation design. The FE study use a randomized, open-label, two-period, two-crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 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
- NCT05922709
- Sponsor's protocol ID
- CS12192-101
- Status last verified
- Oct 2023
- First submitted
- 7 Jun 2023
- Last updated
- 7 Feb 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 7 Feb 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 CS12192 Capsules in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT05922709
- Acronym / sponsor ID
- CS12192-101
- Conditions
- Healthy
- Keywords
- healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 28 Jun 2023 (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 CS12192 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), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study use 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
- 10
- Model description
- The study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study use a randomized, double-blind, placebo-controlled dose-escalation design. The FE study use a randomized, open-label, two-period, two-crossover design.
| Arm | Type | Receives |
|---|---|---|
| CS12192 Cohort 1 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive a single dose of 50 mg CS12192 or matching placebo. |
| CS12192 Cohort 2 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive a single dose of 150 mg CS12192 or matching placebo. |
| CS12192 Cohort 3 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive a single dose of 200 mg CS12192 or matching placebo. |
| CS12192 Cohort 4 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive a single dose of 300 mg CS12192 or matching placebo. |
| CS12192 Cohort 5 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive a single dose of 400 mg CS12192 or matching placebo. |
| CS12192 Cohort 6 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive 200 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. |
| CS12192 Cohort 7 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive 300 mg CS12192 or matching placebo, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. |
| CS12192 Cohort 8 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive 400 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. |
| CS12192 Cohort 9 | Experimental | Drug: CS12192 capsuleSubjects receive a single dose 400 mg CS12192 in either the fasted or fed state for two periods. |
| CS12192 Cohort 10 | Experimental | Drug: CS12192 capsule, Drug: Placebo capsuleSubjects receive a single dose of 600 mg CS12192 or matching placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects, both male and female.
- Between18 and 45 years of age (inclusive) at screening visit.
- BMI between 19.0-26.0 kg/m2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
- All subjects and female partners of male agree to use medically recognized effective contraceptive measures (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.
Key exclusion criteria (26 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 disease or lung, hematological, immunological, psychiatric diseases and metabolic abnormalities.
- History or surgical history of gastrointestinal, hepatic, or renal disease that can affect drug absorption or metabolism within 6 months prior to the screening visit (except uncomplicated appendectomy and hernia repair).
- History of active tuberculosis, or positive tuberculosis screening at screening visit.
- History of any recurrent bacterial, fungal or viral infections (≥3 attacks in the past year, except the common cold), or active infections requiring treatment at screening visit, or history of infection requiring intravenous anti-infective drugs or hospitalization ≤8 weeks before randomization, or history of infection requiring oral anti-infective drugs ≤2 weeks before randomization.
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 |
|---|---|---|
| CS12192 capsuleParticipants receive CS12192 orally single or multiple doses | Drug | CS12192 Cohort 1, CS12192 Cohort 10, CS12192 Cohort 2, CS12192 Cohort 3, CS12192 Cohort 4, CS12192 Cohort 5, CS12192 Cohort 6, CS12192 Cohort 7, CS12192 Cohort 8, CS12192 Cohort 9 |
| Placebo capsuleParticipants receive placebo matching CS12192 orally single or multiple doses | Drug | CS12192 Cohort 1, CS12192 Cohort 10, CS12192 Cohort 2, CS12192 Cohort 3, CS12192 Cohort 4, CS12192 Cohort 5, CS12192 Cohort 6, CS12192 Cohort 7, CS12192 Cohort 8 |
Primary outcome
the Number of Adverse Events (AEs)
Time frame: up to 14 days
To investigate the safety and tolerability by assesment 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 the last dose for food effect study.
Area Under the Plasma Concentration-time Curve of CS12192.
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 the last dose for food effect study.
Maximum Observed Plasma Concentration of CS12192.
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 the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.
Time to reach maximum observed plasma concentration of CS12192.
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 the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.
Plasma Elimination Half-Life of CS12192.
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 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 CS12192 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 5 inclusion and 26 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 7 Feb 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?
the Number of Adverse Events (AEs) (time frame: up to 14 days). 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 7 Feb 2024.