Multiple Ascending Dose Study to Evaluate the Safety, Tolerability of DC371739 Treatment in Hypercholesterolemic

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to initially explore the efficacy and safety in hypercholesterolemia subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou JOYO Pharma Co., Ltd
• Collaborator: The First Hospital of Jilin University

Criteria

Inclusion Criteria:

• Men and women aged 18 to 65 years (inclusive 18 and 65);

• Body mass index of 18 to 32 kg/m2(inclusive);

• Hypercholesterolemia subjects with LDL-C≥2.6mmol/L(100mg/dL);

• Male or female subjects who had no immediate plans to have children, the serum pregnancy test of women was negative at the time of screening, and agreed to use strict contraceptive measures throughout the study period and up to 6 months after the last dose;

Exclusion Criteria:

• ECG confirmed that the QT interval was prolonged > 450ms (QT interval corrected for heart rate by Bazetts formula [QTCB]);

• Use of statins (lovastatin, simvastatin, pravastatin, mevastatin, fluvastatin, atorvastatin, cerivastatin, rosuvastatin, pitavastatin, etc.) , ezetimibe, Xuezhikan, and other lipid-lowering treatment within 2 months prior to screening; use of PCSK9 monoclonal antibodies , fibric acid drugs (such as fenofibrate, gemfibrozil) and probucol within 3 months prior to screening;

• Use of warfarin, systemic steroids, cyclosporine, or other immunosuppressive therapy within months prior to screening;

• Subjects with HIV-AB , HBsAg, ANTI-TP , HCV-AB positive;

• A history of prescription drug abuse and illicit drug abuse within 6 months prior to screening;

• A history of alcohol abuse within 6 months prior to screening;