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

March 15, 2022 updated by: Guangzhou JOYO Pharma Co., Ltd

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.

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ji Lin
      • Changchun, Ji Lin, China
        • The First Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DC371739 20mg Dose MAD
Orally administered DC371739 tablets QD afer meal
Participants received one of 5 dose levels of DC371739 administered as single oral doses.
Placebo Comparator: DC371739 Placebo MAD
Placebo orally administered
Placebo orally administered as comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tolerability evaluation
Time Frame: From informed consent until Day 42.
12-lead ECG
From informed consent until Day 42.
Safety evaluation
Time Frame: From informed consent until Day 42.
adverse events (AE/SAEs)
From informed consent until Day 42.
Pharmacodynamic evaluation
Time Frame: From informed consent until Day 31.
Cmax
From informed consent until Day 31.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective evaluation
Time Frame: From informed consent until Day 29.
LDL-C
From informed consent until Day 29.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

May 29, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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