- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04927221
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability of DC371739 Treatment in Hypercholesterolemic
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ji Lin
-
Changchun, Ji Lin, China
- The First Hospital of Jilin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JYD0102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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