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

NCT ID: NCT04640012

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2022-03-15

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.

Detailed Description

This is a randomized, double-blind , placebo-controlled, single-dose study in 43 male healthy subjects assigned to one of the six dose groups (30mg、50mg、100mg、 200mg、400mg and 600mg). 30mg dose group is the pilot group with 3 subjects. Each of the other dose groups will include 8 subjects (7 for DC371739 and 1 for placebo). Subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. Subjects from different dose groups were enrolled in turn, the next dose group was conducted on the premise that the D6 safety evaluation was completed after the administration of the previous dose group with the result was tolerance. Blood samples will be collected for each group after administration for pharmacokinetic data analysis. Urine and feces were collected in three dose groups of 100 mg, 200 mg and 400 mg respectively to explore the pharmacokinetic characteristics of urine and feces.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DC371739 100mg

Single dose of 100 mg tablet orally administered

Group Type: EXPERIMENTAL

DC371739

Intervention Type: DRUG

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

Placebo

Placebo orally administered

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo orally administered

Interventions

DC371739

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

Intervention Type: DRUG

Placebo

Placebo orally administered

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18-40 years, inclusive, male;

2. Weight≥50kg; body mass index of 19 to 26 kg/m2, inclusive;

3. 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;

Exclusion Criteria

1. Subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution

2. 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;

3. 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;

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou JOYO Pharma Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Song Ai yun, Phd.MD.

Role: STUDY_DIRECTOR

Guang zhou JOYO Pharma

Locations

Shanghai Xu hui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

JYD0101

Identifier Type: -

Identifier Source: org_study_id