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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

DC371739 Tablets

Placebo

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, Pharmacokinetics, Pharmacodynamics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DC371739 20mg Dose MAD

DC371739 Placebo MAD

Arm Description

Orally administered DC371739 tablets QD afer meal

Placebo orally administered

Outcomes

Primary Outcome Measures

tolerability evaluation

12-lead ECG

Safety evaluation

adverse events (AE/SAEs)

Pharmacodynamic evaluation

Cmax

Secondary Outcome Measures

Effective evaluation

LDL-C

Full Information

NCT ID

NCT04927221

First Posted

May 29, 2021

Last Updated

March 15, 2022

Sponsor

Guangzhou JOYO Pharma Co., Ltd

Collaborators

The First Hospital of Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT04927221

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

December 21, 2021 (Actual)

Study Completion Date

December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou JOYO Pharma Co., Ltd

Collaborators

The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Hypercholesterolemia, Pharmacokinetics, Pharmacodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to one of 5 groups in parallel for the duration of the study

Masking

Participant

Masking Description

Participant, Investigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DC371739 20mg Dose MAD

Arm Type

Experimental

Arm Description

Orally administered DC371739 tablets QD afer meal

Arm Title

DC371739 Placebo MAD

Arm Type

Placebo Comparator

Arm Description

Placebo orally administered

Intervention Type

Drug

Intervention Name(s)

DC371739 Tablets

Intervention Description

Participants received one of 5 dose levels of DC371739 administered as single oral doses.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo orally administered as comparison

Primary Outcome Measure Information:

Title

tolerability evaluation

Description

12-lead ECG

Time Frame

From informed consent until Day 42.

Title

Safety evaluation

Description

adverse events (AE/SAEs)

Time Frame

From informed consent until Day 42.

Title

Pharmacodynamic evaluation

Description

Cmax

Time Frame

From informed consent until Day 31.

Secondary Outcome Measure Information:

Title

Effective evaluation

Description

LDL-C

Time Frame

From informed consent until Day 29.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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;

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Changchun

State/Province

Ji Lin

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35427476

Citation

Wang J, Zhao J, Yan C, Xi C, Wu C, Zhao J, Li F, Ding Y, Zhang R, Qi S, Li X, Liu C, Hou W, Chen H, Wang Y, Wu D, Chen K, Jiang H, Huang H, Liu H. Identification and evaluation of a lipid-lowering small compound in preclinical models and in a Phase I trial. Cell Metab. 2022 May 3;34(5):667-680.e6. doi: 10.1016/j.cmet.2022.03.006. Epub 2022 Apr 14.

Results Reference

derived

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

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