SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

NCT07051603 | Recruiting Phase 1

• 1 other identifier: SAL0140A101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.

Conditions

Uncontrolled Hypertension

Keywords

SAL0140; Uncontrolled hypertension; Pharmacokinetic; Pharmacodynamic

Outcome Measures

Primary Outcomes (2)

• The rate of Adverse events

  The rate of Adverse events occur during the whole study

  from Day 1 to Day8 or Day23 or Day28

• The rate of normality or abnormality of electrocardiogram

  The rate of normality or abnormality of electrocardiogram during the whole study

  from Day 1 to Day8 or Day23 or Day28

Study Arms (3)

Single Ascending Doses (SAD, Part A)

EXPERIMENTAL

In this part, 5 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 6:2 ratio to receive either SAL0140 or placebo.

Drug: SAL0140; Drug: SAL0140 placebo

Experimental: Foode Effect (FE, Part B)

EXPERIMENTAL

12 participants and single dose food effect cohort. This part is open-label, two sequence, two-period, crossover design. Participants will be randomly assigned to 1 of the 2 crossover sequence

Drug: SAL0140

Experimental: Single Ascending Doses (MAD, Part C)

EXPERIMENTAL

In this part, 3 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in an 8:2 ratio to receive either SAL0140 or placebo.

Drug: SAL0140; Drug: SAL0140 placebo

Interventions

SAL0140 DRUG

In this part, SAL0140 tablets will be administered as a single or multiple oral dose.

Experimental: Foode Effect (FE, Part B); Experimental: Single Ascending Doses (MAD, Part C); Single Ascending Doses (SAD, Part A)

SAL0140 placebo DRUG

In this part, SAL0140 placebo tablets will be administered as a single or multiple oral dose.

Experimental: Single Ascending Doses (MAD, Part C); Single Ascending Doses (SAD, Part A)

Eligibility Criteria

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

You may qualify if:

• Subjects has fully understood and voluntarily signed the informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;
• Male or female aged 18-65 years (including 18 and 65 years old);
• Male body weight ≥50kg, female body weight ≥45kg and body mass index (BMI) between 19.0 - 26.0 kg/m2 (including 19.0 and 26.0, BMI = weight(kg) / height(cm)2) at screening;
• All examinations (including physical examination, vital signs, laboratory tests, ECG, chest X-ray (anterior and lateral views), etc.) show no abnormalities or minor abnormalities deemed non clinical signiant by the investigator;

You may not qualify if:

• Subjects with orthostatic tachycardia or orthostatic hypotension at screening; or those with a history of orthostatic hypotension symptoms (such as dizziness, fatigue, blurred vision, pallor upon standing) or orthostatic tachycardia symptoms (such as dizziness, palpitations, tremors, general weakness, blurred vision, exercise intolerance when standing);
• Subjects have used corticosteroids within 3 months prior to dosing;
• Subjects with personal or family history of long QT syndrome, torsades de pointes, or other complex arrhythmias, or family history of sudden death;
• Subjects with prolonged QTcF interval (\>450msec) on ECG;
• Subjects with potassium levels above the upper limit of normal (\>ULN) or sodium levels below the lower limit of normal (\<LLN) in biochemistry tests;
• Subjects with known allergies to excipients in the study drug or history of severe allergic reactions (including food, drugs, insect bites, etc.);
• Subjects with any disease history or current condition that may affect the safety evaluation or drug disposition of the study participant, including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, psychiatric conditions, metabolic disorders, gastrointestinal surgery (except appendectomy), etc.;
• Subjects have undergone gastric surgery, vagotomy, bowel resection, or any surgery that may interfere with gastrointestinal motility, pH, or absorption;
• Subjects received live or attenuated vaccines within 4 weeks prior to screening;
• Subjects consume excessive tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) daily, or have consumed these beverages within 48h prior to dosing, or cannot stop consuming during the trial;
• Subjects have taken any prescription drugs, over-the-counter medications, Chinese herbs, or dietary supplements (including vitamins, health foods, etc.) within 14 days prior to dosing;
• Subjects with a history of long-term consumption of xanthine-rich or grapefruit-containing beverages or foods, or who have consumed any xanthine-rich or grapefruit products within 48h prior to dosing;
• Subjects have smoked within 3 months prior to screening, or cannot stop using any tobacco products during the trial;
• Subjects have participated in other clinical trials and taken any investigational drugs within 3 months prior to screening;
• Subjects have donated blood or lost blood ≥400 mL, received blood transfusion or blood products within 3 months prior to screening;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Study Officials

• Chongyuan Xu, Ph.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chongyuan Xu, Ph.D.

CONTACT

13926186470; nflcyljd@smu.edu.cn

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 17, 2025
• First Posted: July 4, 2025
• Study Start: June 9, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)