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

• ClinicalTrials.gov Identifier: NCT04640012
• Recruitment Status: Active, not recruiting
• First Posted: November 23, 2020
• Last Update Posted: July 28, 2021
• Sponsor: Guangzhou JOYO Pharma Co., Ltd
• Information provided by (Responsible Party): Guangzhou JOYO Pharma Co., Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia	Drug: DC371739; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
• Actual Study Start Date: September 25, 2020
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: DC371739 100mg; Single dose of 100 mg tablet orally administered	Drug: DC371739; Participants received one of 6 dose levels of DC371739 administered as single oral doses.
Placebo Comparator: Placebo; Placebo orally administered	Drug: Placebo; Placebo orally administered

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug until Day 15 in three arms ]
   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.
2. Total urine excretion rate [ Time Frame: From the first dose of study drug until Day 6 ]
   Urine samples will be taken at different time points for analysis in three arms
3. Total feces excretion rate [ Time Frame: From the first dose of study drug until Day 6 ]
   feces samples will be taken at different time points for analysis in three arms

Secondary Outcome Measures :

1. Area under the plasma concentration versus time curve (AUC(0-t)) [ Time Frame: From the first dose of study drug until Day 6 ]
   Blood samples will be taken at different time points before and after administration.
2. Time to reach maximum plasma concentration (Tmax) [ Time Frame: From the first dose of study drug until Day 6 ]
   Blood samples will be taken at different time points before and after administration.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, Shanghai

Shanghai Xu hui Central Hospital

Shanghai, Shanghai, China, 200031

Sponsors and Collaborators

Guangzhou JOYO Pharma Co., Ltd

Investigators

• Study Director: Song Ai yun, Phd.MD.; Guang zhou JOYO Pharma

More Information

• Responsible Party: Guangzhou JOYO Pharma Co., Ltd
• ClinicalTrials.gov Identifier: NCT04640012
• Other Study ID Numbers: JYD0101 V1.0
• First Posted: November 23, 2020
• Last Update Posted: July 28, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guangzhou JOYO Pharma Co., Ltd:

Hyperlipidemia

Additional relevant MeSH terms:

Hyperlipidemias; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases