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

NCT07766759 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: FXR0906-I-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• peak concentration (Cmax)

  Day0-Day3 ( Predose ~ post-dose 48h)

• time to peak (Tmax)

  Day0-Day3 ( Predose ~ post-dose 48h)

• area under the blood drug concentration-time curve from 0 to 24 hours (AUC0-24)

  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)

  Day0-Day3 ( Predose ~ post-dose 48h)

• area under the blood drug concentration-time curve from 0 to infinity (AUC0-inf)

  Day0-Day3 ( Predose ~ post-dose 48h)

Study Arms (3)

Arm1: FXR0906 injection

EXPERIMENTAL

Dose 1 of FXR0906 injection

Drug: Intervention1: FXR0906 injection

Arm2: FXR0906 injection

EXPERIMENTAL

dose 2 of FXR0906 injection

Drug: Intervention2: FXR0906 injection

Arm3: placebo comparator: placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Intervention1: FXR0906 injection DRUG

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

Arm1: FXR0906 injection

Intervention2: FXR0906 injection DRUG

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

Arm2: FXR0906 injection

Placebo DRUG

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

Arm3: placebo comparator: placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \. 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..
• \. 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:
• ALT and/or AST \>1.5 × ULN
• ALT and/or AST \> ULN and ≤1.5 × ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator
• INR \> ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator
• Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2 (using MDRD formula)
• Other examination abnormalities deemed clinically significant and unsuitable for participation in the clinical trial by the investigator

Sponsors & Collaborators

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

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

Central Study Contacts

Yida Tang, PhD

CONTACT

+86 13901010211; tang_yida@163.com

Yu Fu

CONTACT

+86 13671185050; lilac_fu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

CN (1)