Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects

NCT04640012 | Completed Phase 1

• 1 other identifier: JYD0101
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety, tolerability, pharmacokinetics of DC371739 after a single-dose oral administration in healthy Chinese subjects, and to explore the maximum tolerated dose, also the pharmacokinetics of urine and feces.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events

  The relationship of each adverse event to the investigational product was assessed by the investigator.A serious adverse event (SAE) is defined as an adverse event that is fatal is life threatening (places the subject at immediate risk of death) requires in-patient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity other significant medical hazard.

  From the first dose of study drug until Day 15 in three arms

• Total urine excretion rate

  Urine samples will be taken at different time points for analysis in three arms

  From the first dose of study drug until Day 6

• Total feces excretion rate

  feces samples will be taken at different time points for analysis in three arms

  From the first dose of study drug until Day 6

Secondary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC(0-t))

  From the first dose of study drug until Day 6

• Time to reach maximum plasma concentration (Tmax)

  From the first dose of study drug until Day 6

Study Arms (2)

DC371739 100mg

EXPERIMENTAL

Single dose of 100 mg tablet orally administered

Drug: DC371739

Placebo

PLACEBO COMPARATOR

Placebo orally administered

Drug: Placebo

Interventions

DC371739 DRUG

Participants received one of 6 dose levels of DC371739 administered as single oral doses.

DC371739 100mg

Placebo DRUG

Placebo orally administered

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-40 years, inclusive, male;
• Weight≥50kg; body mass index of 19 to 26 kg/m2, inclusive;
• Based on the medical history, physical examination, clinical laboratory examination, 12-lead ECG and vital signs results, subjects with no evidence of active or chronic diseases, or clinically significant abnormalities;

You may not qualify if:

• Subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution
• Presence of symptoms or related history of any major disease, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, nerve, mental and other systemic disease, or any other diseases or physiological conditions that could interfere with the results;
• Any surgical condition or condition that may significantly affect the metabolism and excretion of drug absorption and distribution, or that may pose a hazard to the subjects participating in the study; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the study drug, or any surgical condition or condition that may harm to the subjects participating in the study;
• Subjects who donated blood or lost 400 ml of blood within 3 months prior to screening;
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Shanghai Xu hui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

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

Study Officials

• Song Ai yun, Phd.MD.

  Guang zhou JOYO Pharma

  STUDY DIRECTOR

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: September 25, 2020
• Primary Completion: March 19, 2021
• Study Completion: March 15, 2022
• Last Updated: August 3, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)