HyperlipidemiaPhase 1NCT07722299

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0167 in Healthy Participants

A Phase 1 study testing SAL0167 group in people with Hyperlipidemia, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAL0167 following single and multiple dose administration in healthy participants. The study consists of two parts (Part A and Part B) with 120 participants planned to be enrolled. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hyperlipidemia
What is being tested?: SAL0167 group
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: 21 Jul 2026to 31 Jul 2027
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

Provide written informed consent before any study-specific procedure and be willing and able to comply with the requirements and restrictions specified in the informed consent form;
Male or female, 18 to 65 years of age, inclusive;
At screening, body weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) 19.0 to 28.0 kg/m², inclusive (BMI = weight [kg]/height [m]²);
At screening, no clinically significant findings on physical examination, vital signs, hematology, urinalysis, stool examination, serum chemistry, creatine kinase isoenzyme testing, coagulation tests, serology, or 12-lead ECG, as determined by the investigator; lipid parameters are excepted for Part B;
For Part B, screening LDL-C ≥1.8 and ≤4.9 mmol/L and triglycerides (TG) ≤4.52 mmol/L;
The participant and the participant's partner have no plans for pregnancy during the study or for 3 months after the last dose of investigational product; agree to use effective contraception (hormonal contraceptives are prohibited during the study) to prevent pregnancy; and agree not to donate sperm or ova/oocytes for reproductive or assisted-reproduction purposes.

Who cannot join

Any clinically significant disease or medical history that, in the investigator's judgment, could interfere with study completion, including respiratory, cardiovascular, gastrointestinal, genitourinary, hematologic, endocrine, neurologic, psychiatric, malignant, or infectious disease; any disease or surgical history that could significantly alter drug absorption, metabolism, or elimination (e.g., gastrointestinal surgery, renal surgery, cholecystectomy, or another surgery considered likely to affect drug disposition); or habitual constipation or diarrhea;
A history of a gastrointestinal disorder that, in the investigator's judgment, could affect food or drug absorption, such as recurrent vomiting, inflammatory bowel disease, chronic intestinal disease associated with malabsorption, Roemheld syndrome, or severe hernia;
Severe cardiovascular or cerebrovascular disease within 12 months before screening, including decompensated heart failure, unstable angina, stroke or transient ischemic attack, acute myocardial infarction, or severe arrhythmia; a history of coronary artery bypass grafting or percutaneous coronary intervention; or planned cardiac stent placement or angioplasty during the study;
A clinically significant acute drug or food allergic reaction within 2 weeks before screening; a history of allergy to two or more drugs, foods, or pollens; a history of allergic disease (e.g., asthma, urticaria, or eczematous dermatitis); or known or suspected allergy, hypersensitivity, or clinically significant reaction to SAL0167, a compound of the same class, placebo, or any excipient, as determined by the investigator;
Use of any of the following foods, drugs, or treatments:
Any prescription drug, nonprescription drug, Chinese herbal medicine, or dietary supplement (including vitamins or health supplements) within 2 weeks or 5 half-lives, whichever is longer, before screening;

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Current or previous treatment with inclisiran sodium or another investigational small interfering RNA (siRNA) PCSK9 inhibitor;
Treatment with an approved or investigational PCSK9 inhibitor or a microsomal triglyceride transfer protein inhibitor (e.g., lomitapide) within 12 months before screening;
Use of a drug or supplement that may affect cholesterol levels (e.g., a statin, ezetimibe, niacin, or omega-3 fatty acids) within 8 weeks before screening;
Consumption of caffeine-containing (e.g., strong tea, coffee, or cola) or xanthine-rich (e.g., chocolate or cocoa) foods or beverages within 48 hours before the first dose, or unwillingness to abstain from these foods and beverages from 48 hours before the first dose through study completion;
Receipt of a live vaccine, live-attenuated vaccine, or vaccine containing a live viral component within 3 months before screening, or planned receipt of such a vaccine during the study or within 1 month after study completion;
Major trauma or major surgery (e.g., requiring general anesthesia) within 3 months before screening, or planned surgery during the study or within 3 months after study completion, except a procedure performed under local anesthesia;
Participation in an interventional clinical study, including a study of an investigational drug or vaccine, another clinical study of SAL0167, or another cohort of this study, and receipt of investigational product within 3 months before screening;
Blood donation (including apheresis) or blood loss ≥400 mL within 3 months before screening; blood donation or blood loss ≥200 mL, or receipt of a blood transfusion, within 1 month before screening; or planned donation of blood or blood components during the study or within 1 month after study completion;
Difficulty with blood collection, inability to tolerate repeated venipuncture, or a clinically significant history of needle or blood phobia, as determined by the investigator;
Difficulty swallowing or dietary requirements that preclude compliance with the standardized diet;
Pregnant or breastfeeding female; positive pregnancy test in a female participant of childbearing potential; or unprotected sexual intercourse within 14 days before screening in a female participant of childbearing potential;
Drug or substance abuse, excessive alcohol use, or heavy smoking, as evidenced by any of the following:
History of drug or substance abuse, or a positive urine drug screen at screening;
Average alcohol consumption of more than 14 units per week within 3 months before screening (1 unit is approximately 17.7 mL ethanol, equivalent to approximately 360 mL of 5% beer, 45 mL of 40% spirits, or 150 mL of 12% wine); a positive breath alcohol test at screening; or inability to abstain completely from alcohol-containing foods or beverages during the study;
Average smoking of more than 5 cigarettes per day within 3 months before screening, or inability to abstain completely from tobacco products during the study;
QTcF >450 ms for males or >470 ms for females;
Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum-specific antibody;
Poor anticipated compliance, as determined by the investigator, or any other factor that makes the participant unsuitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chongyuan Xu contact

13926186470

nflcyljd@smu.edu.cn

China1 site

Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Chongyuan Xu, 13926186470, nflcyljd@smu.edu.cn

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0167 Tablets in Healthy Participants

Conditions: Hyperlipidemia
Being tested: SAL0167 group, SAL0167 placebo group
Keywords: Hyperlipidemias, Low-Density Lipoprotein-Cholesterol
Medical subject headings: Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAL0167 groupDrug
Drug: SAL0167
SAL0167 placebo groupDrug
Drug: SAL0167 placebo

Study groups in NCT07722299
Study group	Role	What they receive
Experimental group	Experimental	Not described Receives: Drug: SAL0167 group
Placebo group	Placebo comparator	Not described Receives: Drug: SAL0167 placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Adverse Events throughout the entire trial
Measured: through study completion, an average of 50 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202631 Jul 2027

First posted23 Jul 2026
Study start21 Jul 2026 (estimated)
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyperlipidemiaStudies 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: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07722299
Sponsor's protocol ID: SAL0167A101
Status last verified: Jul 2026
First submitted: 17 Jul 2026
Last updated: 23 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Chongyuan Xu

13926186470

nflcyljd@smu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0167 Tablets in Healthy Participants
ClinicalTrials.gov ID: NCT07722299
Acronym / sponsor ID: SAL0167A101
Conditions: Hyperlipidemia
Keywords: Hyperlipidemias, Low-Density Lipoprotein-Cholesterol
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Jul 2026 (estimated)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2027 (estimated)
First posted: 23 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: SAL0167 group
Placebo group	Placebo comparator	Drug: SAL0167 placebo group

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provide written informed consent before any study-specific procedure and be willing and able to comply with the requirements and restrictions specified in the informed consent form;
Male or female, 18 to 65 years of age, inclusive;
At screening, body weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) 19.0 to 28.0 kg/m², inclusive (BMI = weight [kg]/height [m]²);
At screening, no clinically significant findings on physical examination, vital signs, hematology, urinalysis, stool examination, serum chemistry, creatine kinase isoenzyme testing, coagulation tests, serology, or 12-lead ECG, as determined by the investigator; lipid parameters are excepted for Part B;
For Part B, screening LDL-C ≥1.8 and ≤4.9 mmol/L and triglycerides (TG) ≤4.52 mmol/L;

Key exclusion criteria (24 listed)

Any clinically significant disease or medical history that, in the investigator's judgment, could interfere with study completion, including respiratory, cardiovascular, gastrointestinal, genitourinary, hematologic, endocrine, neurologic, psychiatric, malignant, or infectious disease; any disease or surgical history that could significantly alter drug absorption, metabolism, or elimination (e.g., gastrointestinal surgery, renal surgery, cholecystectomy, or another surgery considered likely to affect drug disposition); or habitual constipation or diarrhea;
A history of a gastrointestinal disorder that, in the investigator's judgment, could affect food or drug absorption, such as recurrent vomiting, inflammatory bowel disease, chronic intestinal disease associated with malabsorption, Roemheld syndrome, or severe hernia;
Severe cardiovascular or cerebrovascular disease within 12 months before screening, including decompensated heart failure, unstable angina, stroke or transient ischemic attack, acute myocardial infarction, or severe arrhythmia; a history of coronary artery bypass grafting or percutaneous coronary intervention; or planned cardiac stent placement or angioplasty during the study;
A clinically significant acute drug or food allergic reaction within 2 weeks before screening; a history of allergy to two or more drugs, foods, or pollens; a history of allergic disease (e.g., asthma, urticaria, or eczematous dermatitis); or known or suspected allergy, hypersensitivity, or clinically significant reaction to SAL0167, a compound of the same class, placebo, or any excipient, as determined by the investigator;
Use of any of the following foods, drugs, or treatments:

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
SAL0167 groupDrug: SAL0167	Drug	Experimental group
SAL0167 placebo groupDrug: SAL0167 placebo	Drug	Placebo group

Primary outcome

Adverse events
Time frame: through study completion, an average of 50 days
Adverse Events throughout the entire trial

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 23 Jul 2026.

Related trials for Hyperlipidemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

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.

Chongyuan Xu contact

13926186470

nflcyljd@smu.edu.cn

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 SAL0167 group in people with Hyperlipidemia, 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 24 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: opening soon, as of the sponsor's last update on 23 Jul 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. Some participants in this study may receive a placebo. 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?

Contact Chongyuan Xu (13926186470, nflcyljd@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: through study completion, an average of 50 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07722299.

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 23 Jul 2026.