A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401

NCT ID: NCT06041165

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-09-21

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental: JS401 injection

Group Type: EXPERIMENTAL

JS401

Intervention Type: DRUG

Single dose of JS401 by subcutaneous (sc) injections

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Calculated volume to match active treatment

Interventions

JS401

Single dose of JS401 by subcutaneous (sc) injections

Intervention Type: DRUG

Placebo

Calculated volume to match active treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender;

2. Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening> 1.8 mmol/L (70 mg/dL).

Exclusion Criteria

1. Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials;

2. Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization;

3. Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening;

4. History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening;

5. History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fugui Wang

Role: CONTACT

fugui_wang@junshipharma.com

8613511074153

Facility Contacts

Fangfang Wang, PhD

Role: primary

doctorfancy@126.com

8615611963416

Other Identifiers

JS401-001

Identifier Type: -

Identifier Source: org_study_id