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

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DC739 Multiple-Dose in Hypercholesterolemic Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927221
• Other study ID #: JYD0102
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: May 2021
• Source: Guangzhou JOYO Pharma Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Totally about 30-50 qualified subjects were assigned to one of the following dose groups：20mg, 40mg, 60mg, 80mg, 120 mg (60mg and 120mg is the optional dose group). Each of the dose groups will include 10 subjects (8 for DC739 and 2 for placebo).

Subjects will be admitted for treatment on day -1 and receive the first dose of study drug or placebo on day 1 and then treat for 28 days. Subjects from different dose groups were enrolled in turn, the next dose group is conducted on the premise that the D15 safety evaluation was completed after the administration of the previous dose group with the result was tolerance.

Blood samples will be collected on day 1 for 48 hours and day 28 for 72 hours after administration for pharmacokinetic data analysis. Blood lipid will be collected for effectiveness evaluation. PCSK9 and ANGPTL3, Urine and feces were collected for explore analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• DC371739 Tablets
Participants received one of 5 dose levels of DC371739 administered as single oral doses.
• Placebo
Placebo orally administered as comparison

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Ji Lin

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerability evaluation	12-lead ECG	From informed consent until Day 42.
Primary	Safety evaluation	adverse events (AE/SAEs)	From informed consent until Day 42.
Primary	Pharmacodynamic evaluation	Cmax	From informed consent until Day 31.
Secondary	Effective evaluation	LDL-C	From informed consent until Day 29.