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

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FXR0906 in Healthy Adult Participants With or Without Elevated Triglycerides

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Volunteers
• Intervention / Treatment: Drug: Intervention1: FXR0906 injection; Drug: Intervention2: FXR0906 injection; Drug: Placebo

Detailed Description

This phase 1 study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of FXR0906 injection in healthy adults with or without TG increase. Eligible enrolled participants will be randomized to 3 groups receiving FXR0906 (dose 1 or dose 2) or placebo on Day 1 and will be followed up for about 26 weeks

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yida Tang, PhD; Phone Number: +86 13901010211; Email: tang_yida@163.com
• Study Contact Backup: Name: Yu Fu; Phone Number: +86 13671185050; Email: lilac_fu@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Peking University Third Hospital
      • Contact: Haiyan Li; Phone Number: +86 010 82266226; Email: haiyanli1027@hotmail.com
      • Contact: Yan Xu; Phone Number: +86 010 82265757; Email: bysygcpoffice@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm1: FXR0906 injection; Dose 1 of FXR0906 injection	Drug: Intervention1: FXR0906 injection; A single dose of FXR0906 (dose 1 ) will be administered on Day 1 by subcutaneous injection
Experimental: Arm2: FXR0906 injection; dose 2 of FXR0906 injection	Drug: Intervention2: FXR0906 injection; A single dose of FXR0906 (dose 2) will be administered on Day 1 by subcutaneous injection
Placebo Comparator: Arm3: placebo comparator: placebo; placebo	Drug: Placebo; the volume mached placebo is normal saline (0.9%) and will be administered on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety	the incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with FXR0906	through study completion, an average of 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak concentration (Cmax)	PK parameters	Day0-Day3 ( Predose ~ post-dose 48h)
time to peak (Tmax)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to 24 hours (AUC0-24)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to the last measurable blood drug concentration time t (AUC0-t)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to infinity (AUC0-inf)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
terminal elimination rate constant (λz)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
elimination half-life (t1/2)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
apparent clearance (CL/F)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
apparent volume of distribution (Vz/F)	PK parameter	Day0-Day3 ( Predose ~ post-dose 48h)
Pharmacodynamic (PD) parameters	This investigation will assess the changes in fasting serum APOC3 and triglyceride (TG) levels over time	through study completion, an average of 26 weeks

Collaborators and Investigators

• Sponsor: Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 14, 2026

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FXR0906-I-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No