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A Randomized, double-blind, placebo-controlled, single-dose, multiple-dose, phase I trial for evaluation of tolerance, pharmacokinetics and pharmacodynamics of S086 in healthy volunteers

A Randomized, double-blind, placebo-controlled, single-dose, multiple-dose, phase I trial for evaluation of tolerance, pharmacokinetics and pharmacodynamics of S086 in healthy volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020334
Enrollment
Unknown
Registered
2018-12-24
Start date
2018-12-21
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Heart failure, Hypertension

Interventions

60mg SAD:S086 60mg Tablets
180mg SAD:S086 180mg Tablets
360mg SAD:S086 360mg Tablets
540mg SAD :S086 540mg Tablets
720mg SAD:S086 720mg Tablets
960mg SAD:S086 960mg Tablets
1080mg SAD:S086 1080mg Tablets
180mg MAD:S086 180mg Tablets
360mg MAD:S086 360mg Tablets
540mg MAD:S086 540mg Tablets
720mg MAD:S086 720mg Tablets

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 old (including 18 and 55 years old); 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

Exclusion criteria

Exclusion criteria: 1. Amount of smoking >5 cigarets per day within 3 months prior to study; 2. Allergy to sacuibitril, alizartan isoproxil, losartan, valsartan and their integridients; 3. History of drugs addicted and/or alcohol abuse (14 units of alcohol per week: 1 unit=285 mL of beer, or 25 mL of liquor, or 100 mL red wine); 4. History of drugs abuse within 5 years; 5. Blood donation or blood lossing > 450mL prior to administration of drugs; 6. Difficulty in swallowing or history of any GI diseases affecting the absorption of drugs; 7. High risk in bleeding; 8. Angio-edema and etc.

Design outcomes

Primary

MeasureTime frame
Blood pressure;cGMP;pulse;

Countries

China

Contacts

Public ContactYanhua Ding

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