Healthy ParticipantsPhase 1NCT07745114
SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a)
A Phase 1 study testing Single Ascending Dose and Once Daily (QD), Multiple Ascending Dose (MAD) in people with Healthy Participants and Elevated Lp(a), run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is divided into 3 parts: Part A, Part B, and Part C. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of SAL0137 tablets; Part B is a randomized, double-blind… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Elevated Lp(a)
- What is being tested?
- Single Ascending Dose and Once Daily (QD), Multiple Ascending Dose (MAD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2026to 30 Sep 2026
- 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
- Have fully understood the study and voluntarily sign the written informed consent form, and are able to comply with the requirements and restrictions listed in the informed consent form;
- Male or female participants aged 18 to 65 years (inclusive);
- At screening, weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 19.0 and 28.0 kg/m2 (inclusive; BMI = weight ÷ height2);
- At screening, results of all examinations (including physical examination, vital signs, hematology, urinalysis, blood chemistry, coagulation tests, viral serology and 12-lead electrocardiogram) other than Lp(a) are normal or have minor abnormalities judged by the investigator to be of no clinical significance, where fibrinogen should not be below the lower limit of the normal range.
- At screening, Lp(a) for participants in Part B and Part C should be ≥75 nmoL/L（or 300 mg/L）;
- The participants or their partners have no plans for pregnancy during the study and for 6 months after the last dose of the study drug, and are willing to use effective contraceptive measures (the use of contraceptive pills is prohibited during the study). In addition, the participants will not donate sperm or eggs (oocytes) for reproductive or assisted reproductive purposes.
Who cannot join
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy screening result, or female participants of childbearing potential who have had unprotected sexual intercourse within 14 days before the first dose;
- Any disease (e.g., acute gastritis, gastrointestinal ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.) or medical history (e.g., history of intracranial haemorrhage, history of intraocular haemorrhage, history of haemophilia, history of von Willebrand disease, etc.) that, in the investigator's judgment, could alter or increase the haemorrhagic diathesis;
- History of clinically significant acute drug or food allergy within 2 weeks before screening, or allergic diathesis (e.g., allergy to two or more drugs, foods, or pollens), or a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or known or suspected allergy, hypersensitivity, or clinically significant reaction to the investigational product (including similar drugs or the control drug) or any of its excipients, as judged by the investigator;
- Positive result for any of the following tests: hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum specific antibody;
- Use of any of the following foods, drugs, or treatments before the first dose:
- Use of any inhibitors or inducers of metabolic enzymes and transporters within 2 weeks before the first dose;
Show all 21Show fewer
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and dietary supplements (including vitamins, health products, etc.) within 2 weeks before the first dose;
- Consumption of foods or beverages containing grapefruit from 48 hours before the first dose until study withdrawal;
- Consumption of foods or beverages containing caffeine (e.g., strong tea, coffee, cola) or rich in xanthine (e.g., chocolate, cocoa beans) from 48 hours before the first dose until study withdrawal.
- Illicit drug use or drug abuse, alcoholism, or heavy smoking:
- History of illicit drug use or drug abuse, or a positive urine drug screen at screening;
- Average weekly alcohol use of more than 14 units in the 3 months prior to screening (1 unit ≈17.7 mL of ethanol, i.e., 1 unit ≈360 mL of 5% alcohol beer, or 45 mL of 40% alcohol liquor, or 150 mL of 12% alcohol wine), or a positive alcohol breath test at screening, or inability to completely abstain from any food or beverage containing alcohol during the study;
- Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to completely abstain from any tobacco products during the study;
- Blood donation (including component donation) or blood loss ≥400 mL within 3 months before screening, blood donation (including component donation) or blood loss ≥200 mL or have received a transfusion within 1 month before screening, or plans to donate blood or blood components during the study or within 1 month after the end of the study;
- Difficulty with blood sampling or inability to tolerate multiple venipunctures, or a clinically significant history of needle or blood phobia as judged by the investigator;
- Have dysphagia, or have special dietary requirements and cannot adhere to the standardized diet;
- Have received a live vaccine, live attenuated vaccine, or any vaccine with live viral components within 3 months before screening, or plan to receive such vaccines during the study or within 1 month after the end of the study;
- Have experienced severe trauma or have received major surgery (e.g., requiring general anaesthesia) within 3 months before screening, or plan to undergo surgery (except for surgery under local anaesthesia) during the study or within 3 months after the end of the study;
- Have participated in or are currently participating in any interventional clinical study (including investigational drugs or vaccines, as well as other clinical studies of this investigational product or other groups of this study) and received an investigational product within 3 months before screening; or have received siRNA drugs within the past 12 months; or have received antisense oligonucleotide drugs/antibody drugs within the past 6 months;
- Presence of other clinically significant diseases or medical history that, in the investigator's judgment, may interfere with the participant's ability to complete this study (including diseases or disorders involving the respiratory, cardiovascular, digestive, urogenital, hematologic, endocrine, neurological, and psychiatric systems, as well as malignancies), or other diseases or medical history that may significantly alter drug absorption, metabolism, or clearance (e.g., history of surgery judged to potentially affect the in vivo disposition of the drug, such as gastrointestinal surgery, renal surgery, or cholecystectomy), or infectious diseases;
- Male study participants with QTCF > 450 ms, female study participants with QTCF > 470 ms; 15）Poor compliance as judged by the investigator, or any other factors that make the participant unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of ANHUI Medical University
Hefei, Anhui, 230088
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0137 Tablets in Healthy Participants With or Without Elevated Lp(a)
This study is divided into 3 parts: Part A, Part B, and Part C. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of SAL0137 tablets; Part B is a randomized, double-blind, placebo-controlled, multiple ascending dose study with once-daily administration for 14 consecutive days to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple QD oral doses of SAL0137 tablets.
- Conditions
- Healthy Participants, Elevated Lp(a)
- Being tested
- Single Ascending Dose, Once Daily (QD), Multiple Ascending Dose (MAD)
- Keywords
- SAL0137, Single and multiple ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Ascending DoseDrug
SAL0137
Single Ascending DoseDrug
Placebo
Once Daily (QD), Multiple Ascending Dose (MAD)Drug
SAL0137
Once Daily (QD), Multiple Ascending Dose (MAD)Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Single Ascending Dose; Drug: Once Daily (QD), Multiple Ascending Dose (MAD) |
| Part B | Experimental | Not described Receives: Drug: Single Ascending Dose; Drug: Once Daily (QD), Multiple Ascending Dose (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security Index
Security Index：Adverse Events (AEs)
Measured: Throughout the entire experiment, an average of 6 to 11 weeks.
Security Index
Check any abnormality of Physical examination, vital signs，Clinical Laboratory test，12-lead electrocardiogram or not
Measured: Throughout the entire experiment, an average of 6 to 11 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start4 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745114
- Sponsor's protocol ID
- SAL0137A101
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0137 Tablets in Healthy Participants With or Without Elevated Lp(a)
- ClinicalTrials.gov ID
- NCT07745114
- Acronym / sponsor ID
- SAL0137A101
- Conditions
- Healthy Participants, Elevated Lp(a)
- Keywords
- SAL0137, Single and multiple ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Aug 2026 (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 study is divided into 3 parts: Part A, Part B, and Part C. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of SAL0137 tablets; Part B is a randomized, double-blind, placebo-controlled, multiple ascending dose study with once-daily administration for 14 consecutive days to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple QD oral doses of SAL0137 tablets.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Single Ascending Dose, Drug: Once Daily (QD), Multiple Ascending Dose (MAD) |
| Part B | Experimental | Drug: Single Ascending Dose, Drug: Once Daily (QD), Multiple Ascending Dose (MAD) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have fully understood the study and voluntarily sign the written informed consent form, and are able to comply with the requirements and restrictions listed in the informed consent form;
- Male or female participants aged 18 to 65 years (inclusive);
- At screening, weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 19.0 and 28.0 kg/m2 (inclusive; BMI = weight ÷ height2);
- At screening, results of all examinations (including physical examination, vital signs, hematology, urinalysis, blood chemistry, coagulation tests, viral serology and 12-lead electrocardiogram) other than Lp(a) are normal or have minor abnormalities judged by the investigator to be of no clinical significance, where fibrinogen should not be below the lower limit of the normal range.
- At screening, Lp(a) for participants in Part B and Part C should be ≥75 nmoL/L（or 300 mg/L）;
Key exclusion criteria (21 listed)
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy screening result, or female participants of childbearing potential who have had unprotected sexual intercourse within 14 days before the first dose;
- Any disease (e.g., acute gastritis, gastrointestinal ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.) or medical history (e.g., history of intracranial haemorrhage, history of intraocular haemorrhage, history of haemophilia, history of von Willebrand disease, etc.) that, in the investigator's judgment, could alter or increase the haemorrhagic diathesis;
- History of clinically significant acute drug or food allergy within 2 weeks before screening, or allergic diathesis (e.g., allergy to two or more drugs, foods, or pollens), or a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or known or suspected allergy, hypersensitivity, or clinically significant reaction to the investigational product (including similar drugs or the control drug) or any of its excipients, as judged by the investigator;
- Positive result for any of the following tests: hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum specific antibody;
- Use of any of the following foods, drugs, or treatments before the first dose:
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 |
|---|---|---|
| Single Ascending DoseSAL0137 | Drug | Part A |
| Single Ascending DosePlacebo | Drug | Part B |
| Once Daily (QD), Multiple Ascending Dose (MAD)SAL0137 | Drug | Part A |
| Once Daily (QD), Multiple Ascending Dose (MAD)Placebo | Drug | Part B |
Primary outcome
Security Index
Time frame: Throughout the entire experiment, an average of 6 to 11 weeks.
Security Index：Adverse Events (AEs)
Security Index
Time frame: Throughout the entire experiment, an average of 6 to 11 weeks.
Check any abnormality of Physical examination, vital signs，Clinical Laboratory test，12-lead electrocardiogram or not
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 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
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
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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 Single Ascending Dose and Once Daily (QD), Multiple Ascending Dose (MAD) in people with Healthy Participants and Elevated Lp(a), 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 6 inclusion and 21 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 4 Aug 2026. 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?
Security Index (time frame: Throughout the entire experiment, an average of 6 to 11 weeks.). The study lists 2 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 4 Aug 2026.