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Not yet recruitingNCT07722299Updated Jul 23, 2026

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

A Phase 1 interventional study of SAL0167 group and SAL0167 placebo group in Hyperlipidemia, sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. Possible adjustments to sample size, treatment duration will depend upon emerging data.

02

Conditions studied

  • Hyperlipidemia

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Keywords

  • Hyperlipidemias
  • Low-Density Lipoprotein-Cholesterol
03

In context

Hyperlipidemias

861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.

This study's planned enrollment of 120 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd. is the lead sponsor of 42 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provide written before any study-specific procedure and be willing and able to comply with the requirements and restrictions specified in the informed consent form;
  2. Male or female, 18 to 65 years of age, inclusive;
  3. At screening, body weight ≥50 kg for males and ≥45 kg for females, and (BMI) 19.0 to 28.0 kg/m², inclusive (BMI = weight [kg]/height [m]²);
  4. At screening, no findings on physical examination, vital signs, hematology, urinalysis, stool examination, serum chemistry, creatine kinase isoenzyme testing, coagulation tests, serology, or 12-lead , as determined by the investigator; lipid parameters are excepted for Part B;
  5. For Part B, screening LDL-C ≥1.8 and ≤4.9 mmol/L and triglycerides (TG) ≤4.52 mmol/L;
  6. The participant and the participant's partner have no plans for pregnancy during the study or for 3 months after the last dose of product; agree to use effective (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.

Exclusion criteria

Exclusion Criteria:

  1. Any 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;
  2. 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;
  3. Severe cardiovascular or cerebrovascular disease within 12 months before screening, including decompensated heart failure, unstable angina, stroke or , 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;
  4. 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, , or clinically significant reaction to SAL0167, a compound of the same class, placebo, or any , as determined by the investigator;
  5. Use of any of the following foods, drugs, or treatments:

    1. 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;
    2. Current or previous treatment with inclisiran sodium or another small interfering RNA (siRNA) PCSK9 inhibitor;
    3. Treatment with an approved or investigational PCSK9 inhibitor or a microsomal triglyceride transfer protein inhibitor (e.g., lomitapide) within 12 months before screening;
    4. 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;
    5. 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;
  6. Receipt of a , 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;
  7. 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;
  8. 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;
  9. 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;
  10. Difficulty with blood collection, inability to tolerate repeated venipuncture, or a clinically significant history of needle or blood phobia, as determined by the investigator;
  11. Difficulty swallowing or dietary requirements that preclude compliance with the standardized diet;
  12. Pregnant or breastfeeding female; positive pregnancy test in a female participant of ; or unprotected sexual intercourse within 14 days before screening in a female participant of childbearing potential;
  13. Drug or substance abuse, excessive alcohol use, or heavy smoking, as evidenced by any of the following:

    1. History of drug or substance abuse, or a positive urine drug screen at screening;
    2. 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;
    3. 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;
  14. >450 ms for males or >470 ms for females;
  15. Positive test result for surface antigen, virus antibody, antibody, or Treponema pallidum-specific antibody;
  16. Poor anticipated compliance, as determined by the investigator, or any other factor that makes the participant unsuitable for the study.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Drug: SAL0167 group

  • Placebo comparator
    Placebo group

    Drug: SAL0167 placebo group

Interventions

  • DrugSAL0167 group

    Drug: SAL0167

  • DrugSAL0167 placebo group

    Drug: SAL0167 placebo

06

What researchers measure

Primary outcomes

  1. Adverse events

    Adverse Events throughout the entire trial

    Time frame: through study completion, an average of 50 days

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.

Of 47 industry-sponsored phase 1 interventional studies under Hyperlipidemias, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's planned 12 months is above that.

Counting every sponsor, half of 54 studies reached it within 3 months; a quarter within 1 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Jul 23, 2026
StartEst.
Jul 21, 2026
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Jul 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07722299
Responsible party
Sponsor
First posted
Jul 23, 2026
Start date
Jul 21, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jul 23, 2026

Study contacts

Chongyuan Xu
Contact
nflcyljd@smu.edu.cn
13926186470

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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