PharmacokineticsPhase 1NCT07030504
To Evaluate the Safety, Tolerability and Pharmacokinetic of SAL0133 Tablets in Chinese Adult Healthy Subjects
A Phase 1 study testing SAL0133 in people with Pharmacokinetics, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- SAL0133
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to Jun 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.
- Healthy male or female adults aged 18 to 65 years (inclusive).The gender ratio shall be no less than one third.
- Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2).
- No abnormalities or only slight abnormalities not clinically significant of tests/examinations (including physical examination, vital sign examination, blood routine, urine routine, blood biochemistry, coagulation function, five thyroid function tests, five pituitary function tests, serological virology, 12-lead electrocardiogram, normal chest position, abdominal B-ultrasound, etc) as judged by the investigator.
- The subject or their partner had no pregnancy plans during the study period and within one month after the last administration of the study drug, and the subjects do not donate sperm or eggs (oocytes, oocytes) for reproductive or assisted reproductive purposes.
Who cannot join
- Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.
- A history of clinically significant drug allergies or allergic diseases (such as asthma, urticaria, eczema).
- Dermatitis, etc., or as determined by the investigator, it may or is clear to be effective against the research drug (including similar drugs and controls) or allergy to the medicine and any of its excipients. Clinically significant underlying liver diseases or medical history, including chronic hepatitis B, chronic hepatitis C, and alcohol liver disease and metabolism-related fatty liver disease, etc.
- Fever symptom or active infection within one week before the first administration of the drug.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or the total bilirubin (TBIL) is higher than the upper limit of the normal value (ULN) during screening.
- Have undergone gastric surgery, vagotomy, intestinal resection or any other procedures that might interfere with the gastrointestinal tract surgical procedures for peristalsis, pH or absorption.
Show all 13Show fewer
- Have received active or attenuated vaccines within 4 weeks before screening. ·Any of the following drugs or treatments were used before the first administration.
- Drug or drug abuse, alcohol abuse, smoking addiction or special diet, etc. Any one of the antibody results is positive: Hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus (HIV).
- Have participated in clinical studies of other drugs and taken any clinical study drugs within 3 months prior to the screening.
- Who have donated blood or lost ≥400 mL of blood, received blood transfusion or used blood products within 3 months prior to the screening.
- There is any disease history or current illness that may affect the safety of the subjects or the in vivo process of the investigational drug, including but not limited to the central nervous system, cardiovascular system, digestive system, respiratory system and endocrine system, urinary system, blood system, immune system, psychiatry, metabolic disorders, and those who have undergone gastrointestinal surgery (Except for cauditis surgery), etc.
- History of fainting from needles or blood, and it has been judged by the researcher to be of clinical significance.
- Any other reason, the researcher determines that the subject is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of SAL0133 Tablets in Chinese Adult Healthy Subjects
To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.
Read the detailed description
This study was divided into two parts: Part A and Part B. Part A was single-center, randomized, double-blind, and placebo control, single-dose escalation study (SAD) was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after a single dose. Furthermore, food effect would be preliminarily evaluated the influence of the pharmacokinetic characteristics of SAL0133 tablets in Part A. Part B was a single-center, randomized, double-blind, placebo controlled, multiple-dose escalation study was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after multiple doses.
- Conditions
- Pharmacokinetics
- Being tested
- SAL0133, SAL0133 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL0133Drug
Also called active drug group
once daily single dose or seven days multiple dose of SAL0133 tables
SAL0133 placeboDrug
Also called placebo group
once daily single dose or seven days multiple dose of SAL0133 placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD 50mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fasting condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| SAD 150mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fasting condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| SAD 300mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fasting condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| SAD 150mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fed condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| SAD 300mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fed condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| SAD 600mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fed condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| MAD 150mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| MAD 150mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
| MAD 300mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition Receives: Drug: SAL0133; Drug: SAL0133 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of AE
The rate of AE occurred in the whole study
Measured: from Day 1 to Day 5 or Day 10
The rate of SAE
The rate of SAE occurred in the whole study
Measured: from Day 1 to Day 5 or Day 10
blood pressure
the change (mmHg) of blood pressure including SBP and DBP in the whole study
Measured: from Day 1 to Day 5 or Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start10 Jan 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongying Yang, M.D, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030504
- Sponsor's protocol ID
- SAL0133A101
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 22 Jun 2025
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of SAL0133 Tablets in Chinese Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT07030504
- Acronym / sponsor ID
- SAL0133A101
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Jun 2025 (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.
To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.
Detailed description
This study was divided into two parts: Part A and Part B. Part A was single-center, randomized, double-blind, and placebo control, single-dose escalation study (SAD) was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after a single dose. Furthermore, food effect would be preliminarily evaluated the influence of the pharmacokinetic characteristics of SAL0133 tablets in Part A. Part B was a single-center, randomized, double-blind, placebo controlled, multiple-dose escalation study was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SAD 50mg Fasting | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily under fasting condition |
| SAD 150mg Fasting | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily under fasting condition |
| SAD 300mg Fasting | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily under fasting condition |
| SAD 150mg Fed | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily under fed condition |
| SAD 300mg Fed | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily under fed condition |
| SAD 600mg Fed | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily under fed condition |
| MAD 150mg Fasting | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition |
| MAD 150mg Fed | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition |
| MAD 300mg Fed | Experimental | Drug: SAL0133, Drug: SAL0133 placebo6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.
- Healthy male or female adults aged 18 to 65 years (inclusive).The gender ratio shall be no less than one third.
- Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2).
- No abnormalities or only slight abnormalities not clinically significant of tests/examinations (including physical examination, vital sign examination, blood routine, urine routine, blood biochemistry, coagulation function, five thyroid function tests, five pituitary function tests, serological virology, 12-lead electrocardiogram, normal chest position, abdominal B-ultrasound, etc) as judged by the investigator.
- The subject or their partner had no pregnancy plans during the study period and within one month after the last administration of the study drug, and the subjects do not donate sperm or eggs (oocytes, oocytes) for reproductive or assisted reproductive purposes.
Key exclusion criteria (13 listed)
- Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.
- A history of clinically significant drug allergies or allergic diseases (such as asthma, urticaria, eczema).
- Dermatitis, etc., or as determined by the investigator, it may or is clear to be effective against the research drug (including similar drugs and controls) or allergy to the medicine and any of its excipients. Clinically significant underlying liver diseases or medical history, including chronic hepatitis B, chronic hepatitis C, and alcohol liver disease and metabolism-related fatty liver disease, etc.
- Fever symptom or active infection within one week before the first administration of the drug.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or the total bilirubin (TBIL) is higher than the upper limit of the normal value (ULN) during screening.
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 |
|---|---|---|
| SAL0133Also: active drug grouponce daily single dose or seven days multiple dose of SAL0133 tables | Drug | MAD 150mg Fasting, MAD 150mg Fed, MAD 300mg Fed, SAD 150mg Fasting, SAD 150mg Fed, SAD 300mg Fasting, SAD 300mg Fed, SAD 50mg Fasting, SAD 600mg Fed |
| SAL0133 placeboAlso: placebo grouponce daily single dose or seven days multiple dose of SAL0133 placebo | Drug | MAD 150mg Fasting, MAD 150mg Fed, MAD 300mg Fed, SAD 150mg Fasting, SAD 150mg Fed, SAD 300mg Fasting, SAD 300mg Fed, SAD 50mg Fasting, SAD 600mg Fed |
Primary outcome
The rate of AE
Time frame: from Day 1 to Day 5 or Day 10
The rate of AE occurred in the whole study
The rate of SAE
Time frame: from Day 1 to Day 5 or Day 10
The rate of SAE occurred in the whole study
blood pressure
Time frame: from Day 1 to Day 5 or Day 10
the change (mmHg) of blood pressure including SBP and DBP in the whole study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- 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.
Hongying Yang, M.D principal investigator
Shenzhen People's Hospital
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 SAL0133 in people with Pharmacokinetics, run by Shenzhen Salubris Pharmaceuticals 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 13 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 rate of AE (time frame: from Day 1 to Day 5 or Day 10). The study lists 3 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 22 Jun 2025.