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A single-center, randomized, open, positive-controlled, parallel-designed phase I clinical study to evaluate the pharmacokinetic, pharmacodynamic, safety and tolerability of S086 in healthy volunteers

A single-center, randomized, open, positive-controlled, parallel-designed phase I clinical study to evaluate the pharmacokinetic, pharmacodynamic, safety and tolerability of S086 in healthy volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046267
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-05-10
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure, Hypertension

Interventions

Experimental group1:S086 120mg
Experimental group2:S086 240mg
Experimental group3:S086 360mg
Experimental group4:LCZ696 200mg
Experimental group5:Losartan potassium150mg

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Signed consent inform, acknowledge of content, procedure and potential adverse reactions of study; 2. Followed by study protocol and complete study; 3. Subjects (including their partners) have no pregnancy plan and voluntary to take effective contraceptive measures 4. Aged 18 to 55 years (including 18 and 55 years); 5. Body weight: Men >= 50kg, Women >=45kg, BMI=kg/m^2, 18-28 kg/m^2 (including 18-28 kg/m^2); 6. Normal hysical examination, vital sign or abnormal but no clinical significance ; 7. 90 mmHg<=SBP<140 mmHg, 60 mmHg<=DBP<90 mmHg.

Exclusion criteria

Exclusion criteria: 1. Average daily smoking >=5 cigarettes within 3 months before screening; 2. Known to have allergic reactions to angiotensin II receptor antagonists such as sacubitril, valsartan sodium, allisartan medoxomil, losartan, valsartan and the auxiliary materials of this product; or allergic physique (a variety of drugs and Food allergies); 3. A history of angioedema; 4. A history of orthostatic hypotension or syncope; 5. A history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = beer 285 mL, or spirits 25 mL , Or wine 100ml); 6. Positive urine drug screening or history of drug abuse or drug use in the past five years; 7. Blood donation or massive blood loss (> 450 mL) within 3 months before screening; 8. Before screening Take any drugs that change the activity of liver enzymes (CYP2C9, CYP3A4) or transporter (OAT1/3, OATP1B1/3, MRP2) inhibitors within 28 days; 9. Take any prescription drugs, over-the-counter drugs, or any vitamins within 14 days before screening Product or herbal medicine; 10. Take a special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks before screening, or have strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion; 11. Before screening 3 Have taken any research drug within a month; 12. Have a history of dysphagia or any gastrointestinal disease that affects the absorption of the drug; 13. Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or stomach and duodenum Ulcers, etc.; 14. 12-lead ECG abnormalities have clinical significance; 15. Female subjects in the screening period or during the trial Are breastfeeding or have a positive serum pregnancy result; 16. Clinical laboratory examinations have clinically significant abnormalities, or other clinical findings within 12 months before screening have shown clinical significance for the following diseases (including but not limited to gastrointestinal tract, kidney, Liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio-cerebrovascular disease); 17. Viral hepatitis (including hepatitis B and C), human immunodeficiency virus antibody, Treponema pallidum antibody screening positive; 18. Screening from Acute illness or concomitant medication from the stage to the study medication; 19. Chocolate, any caffeine-rich or xanthine-rich food or beverage 48 hours before taking the study medication; 20. Alcohol screening positive or taking the study medication Have taken any alcohol-containing products within the previous 48 hours; 21. Subjects who the investigator believes to have other factors that are not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Blood pressure;cyclic guanosinc monophosphate;Amino Terminal b-type natriuretic peptide;Renin concentration;Renin activity;Angiotensinogen II;Aldosterone;

Countries

China

Contacts

Public ContactYDing anhua

The First Hospital of Jilin University

dingyanhua2003@126.com+86 18186879768

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026