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Clinical Trials in China / NCT07766759
Starting soon Phase 1

A Phase 1 Study of FXR0906 in Healthy Adults With or Without Elevated Triglycerides

NCT07766759 · tracked via the Priya Life Science China tracker
Sponsor
Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.
Phase
Phase 1
Started
2026-08-25
Last updated
2026-08-14

Condition(s) studied

Healthy Adult Volunteers

Investigational drug(s) / intervention(s)

Intervention1: FXR0906 injectionIntervention2: FXR0906 injectionPlacebo

Intervention1: FXR0906 injection: A single dose of FXR0906 (dose 1 ) will be administered on Day 1 by subcutaneous injection

Intervention2: FXR0906 injection: A single dose of FXR0906 (dose 2) will be administered on Day 1 by subcutaneous injection

Placebo: the volume mached placebo is normal saline (0.9%) and will be administered on Day 1.

Study summary

This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of FXR0906 injection or placebo in Chinese healthy adult volunteers with or without TG increase.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion criteria: 1\. Males or females aged ≥18 and ≤55 years at the time of screening; 2. Body mass index (BMI) ≥18.0 and ≤35.0 kg/m² at the time of screening, with female participants weighing \>45 kg and male participants weighing \>50 kg; 3. Fasting serum triglyceride (TG) level TG \> 80 mg/dL (0.90 mmol/L) during screening; 4. Fasting LDL-C level ≥ 70 mg/dL (1.81 mmol/L) during screening; Exclusion criteria: 1. History or presence of clinically significant diseases/abnormality, or with clinically significant symptoms/signs, or self-reported diseases, unsuitable for enrollement in the judgement of the investigator. 2\. Fasting blood glucose ≥7.0 mmol/L or HbA1c ≥6.5% during screening. 3. Use of any lipid-lowering treatment (e.g., drugs lowering LDL-C or TG), including but not limited to statins, ezetimibe, fibrates, omega-3 fatty acids, nutritional supplements, or other treatment regimens altering serum lipids within 30 days prior to screening, or use of any ASO or siRNA therapies lowering serum lipids within 12 months prior to screening.. 4\. Use of investigational drugs or instruments within 3 months prior to screening , or plans to participate in other clinical trials during this study. 5. Clinical laboratory parameters during screening meeting any of the following criteria: 1. ALT and/or AST \>1.5 × ULN 2. ALT and/or AST \> ULN and ≤1.5 × ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator 3. INR \> ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator 4. Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2 (using MDRD formula) 5. Other examination abnormalities deemed clinically significant and unsuitable for participation in the clinical trial by the investigator

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766759 on ClinicalTrials.gov ↗ ← All trials in China