Healthy Adult Volunteers
Conditions
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.
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
Interventions
DRUGIntervention1: FXR0906 injection
A single dose of FXR0906 (dose 1 ) will be administered on Day 1 by subcutaneous injection
DRUGIntervention2: FXR0906 injection
A single dose of FXR0906 (dose 2) will be administered on Day 1 by subcutaneous injection
DRUGPlacebo
the volume mached placebo is normal saline (0.9%) and will be administered on Day 1.
Sponsors
Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety | through study completion, an average of 26 weeks | the incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with FXR0906 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peak concentration (Cmax) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameters |
| time to peak (Tmax) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| area under the blood drug concentration-time curve from 0 to 24 hours (AUC0-24) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| 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) | PK parameter |
| area under the blood drug concentration-time curve from 0 to infinity (AUC0-inf) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| terminal elimination rate constant (λz) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| elimination half-life (t1/2) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| apparent clearance (CL/F) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| apparent volume of distribution (Vz/F) | Day0-Day3 ( Predose ~ post-dose 48h) | PK parameter |
| Pharmacodynamic (PD) parameters | through study completion, an average of 26 weeks | This investigation will assess the changes in fasting serum APOC3 and triglyceride (TG) levels over time |
Countries
China
Contacts
CONTACTYida Tang, PhD
CONTACTYu Fu
Outcome results
None listed