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

Sponsor

Guangzhou JOYO Pharma Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT04927221

Collaborator

The First Hospital of Jilin University (Other)

Enrollment

Location

Arms

8.7

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: DC371739 Tablets Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

Participant, Investigator

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Dec 21, 2021

Actual Study Completion Date :

Dec 21, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: DC371739 20mg Dose MAD

Orally administered DC371739 tablets QD afer meal

Drug: DC371739 Tablets

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

Placebo Comparator: DC371739 Placebo MAD

Placebo orally administered

Drug: Placebo

Placebo orally administered as comparison

Outcome Measures

Primary Outcome Measures

tolerability evaluation [From informed consent until Day 42.]
12-lead ECG
Safety evaluation [From informed consent until Day 42.]
adverse events (AE/SAEs)
Pharmacodynamic evaluation [From informed consent until Day 31.]
Cmax

Secondary Outcome Measures

Effective evaluation [From informed consent until Day 29.]
LDL-C

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Jilin University	Changchun	Ji Lin	China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangzhou JOYO Pharma Co., Ltd

ClinicalTrials.gov Identifier:

NCT04927221

Other Study ID Numbers:

JYD0102

First Posted:

Jun 15, 2021

Last Update Posted:

Mar 16, 2022

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guangzhou JOYO Pharma Co., Ltd

Hypercholesterolemia

Pharmacokinetics

Pharmacodynamics

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Mar 16, 2022