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

NCT04927221 | Completed Phase 1

• 1 other identifier: JYD0102
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (3)

• tolerability evaluation

  12-lead ECG

  From informed consent until Day 42.

• Safety evaluation

  adverse events (AE/SAEs)

  From informed consent until Day 42.

• Pharmacodynamic evaluation

  Cmax

  From informed consent until Day 31.

Secondary Outcomes (1)

• Effective evaluation

  From informed consent until Day 29.

Study Arms (2)

DC371739 20mg Dose MAD

EXPERIMENTAL

Orally administered DC371739 tablets QD afer meal

Drug: DC371739 Tablets

DC371739 Placebo MAD

PLACEBO COMPARATOR

Placebo orally administered

Drug: Placebo

Interventions

DC371739 Tablets DRUG

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

DC371739 20mg Dose MAD

Placebo DRUG

Placebo orally administered as comparison

DC371739 Placebo MAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead
• The First Hospital of Jilin University: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• 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.

  PMID: 35427476 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant, Investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 15, 2021
• Study Start: April 1, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: March 16, 2022

Record last verified: 2021-05

Locations

CN (1)