To Evaluate the Safety, Tolerability and Pharmacokinetic of SAL0133 Tablets in Chinese Adult Healthy Subjects

NCT07030504 | Active Not Recruiting Phase 1

• 1 other identifier: SAL0133A101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• The rate of AE

  The rate of AE occurred in the whole study

  from Day 1 to Day 5 or Day 10

• The rate of SAE

  The rate of SAE occurred in the whole study

  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

  from Day 1 to Day 5 or Day 10

Study Arms (9)

SAD 50mg Fasting

EXPERIMENTAL

6 subjects received active drug and 2 subjects received placebo once daily under fasting condition

Drug: SAL0133; Drug: SAL0133 placebo

SAD 150mg Fasting

EXPERIMENTAL

6 subjects received active drug and 2 subjects received placebo once daily under fasting condition

Drug: SAL0133; Drug: SAL0133 placebo

SAD 300mg Fasting

EXPERIMENTAL

6 subjects received active drug and 2 subjects received placebo once daily under fasting condition

Drug: SAL0133; Drug: SAL0133 placebo

SAD 150mg Fed

EXPERIMENTAL

6 subjects received active drug and 2 subjects received placebo once daily under fed condition

Drug: SAL0133; Drug: SAL0133 placebo

SAD 300mg Fed

EXPERIMENTAL

6 subjects received active drug and 2 subjects received placebo once daily under fed condition

Drug: SAL0133; Drug: SAL0133 placebo

SAD 600mg Fed

EXPERIMENTAL

6 subjects received active drug and 2 subjects received placebo once daily under fed condition

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

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

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

Drug: SAL0133; Drug: SAL0133 placebo

Interventions

SAL0133 DRUG

once daily single dose or seven days multiple dose of SAL0133 tables

Also known as: active drug group

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 placebo DRUG

once daily single dose or seven days multiple dose of SAL0133 placebo

Also known as: placebo group

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

Study Officials

• Hongying Yang, M.D

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 22, 2025
• Study Start: January 10, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)