Healthy Adult VolunteersPhase 1NCT07766759
A Phase 1 Study of FXR0906 in Healthy Adults With or Without Elevated Triglycerides
A Phase 1 study testing Intervention1: FXR0906 injection and Intervention2: FXR0906 injection in people with Healthy Adult Volunteers, run by Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Intervention1: FXR0906 injection and Intervention2: FXR0906 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2026to 20 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Haiyan Li, +86 010 82266226, haiyanli1027@hotmail.com
Yan Xu, +86 010 82265757, bysygcpoffice@163.com
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Adult Volunteers
- Being tested
- Intervention1: FXR0906 injection, Intervention2: FXR0906 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention1: FXR0906 injectionDrug
A single dose of FXR0906 (dose 1 ) will be administered on Day 1 by subcutaneous injection
Intervention2: FXR0906 injectionDrug
A single dose of FXR0906 (dose 2) will be administered on Day 1 by subcutaneous injection
PlaceboDrug
the volume mached placebo is normal saline (0.9%) and will be administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: FXR0906 injection | Experimental | Dose 1 of FXR0906 injection Receives: Drug: Intervention1: FXR0906 injection |
| Arm2: FXR0906 injection | Experimental | dose 2 of FXR0906 injection Receives: Drug: Intervention2: FXR0906 injection |
| Arm3: placebo comparator: placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
the incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with FXR0906
Measured: through study completion, an average of 26 weeks
Secondary outcomes (10)
peak concentration (Cmax)
PK parameters
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
time to peak (Tmax)
PK parameter
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to 24 hours (AUC0-24)
PK parameter
Measured: 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
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to infinity (AUC0-inf)
PK parameter
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
terminal elimination rate constant (λz)
PK parameter
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
elimination half-life (t1/2)
PK parameter
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
apparent clearance (CL/F)
PK parameter
Measured: Day0-Day3 ( Predose ~ post-dose 48h)
apparent volume of distribution (Vz/F)
PK parameter
Measured: 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
Measured: through study completion, an average of 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion24 Sep 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766759
- Sponsor's protocol ID
- FXR0906-I-101
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07766759
- Acronym / sponsor ID
- FXR0906-I-101
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1: FXR0906 injection | Experimental | Drug: Intervention1: FXR0906 injectionDose 1 of FXR0906 injection |
| Arm2: FXR0906 injection | Experimental | Drug: Intervention2: FXR0906 injectiondose 2 of FXR0906 injection |
| Arm3: placebo comparator: placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention1: FXR0906 injectionA single dose of FXR0906 (dose 1 ) will be administered on Day 1 by subcutaneous injection | Drug | Arm1: FXR0906 injection |
| Intervention2: FXR0906 injectionA single dose of FXR0906 (dose 2) will be administered on Day 1 by subcutaneous injection | Drug | Arm2: FXR0906 injection |
| Placebothe volume mached placebo is normal saline (0.9%) and will be administered on Day 1. | Drug | Arm3: placebo comparator: placebo |
Primary outcome
safety
Time frame: 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
10 secondary outcomes
peak concentration (Cmax)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
time to peak (Tmax)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to 24 hours (AUC0-24)
Time frame: 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)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
area under the blood drug concentration-time curve from 0 to infinity (AUC0-inf)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
terminal elimination rate constant (λz)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
elimination half-life (t1/2)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
apparent clearance (CL/F)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
apparent volume of distribution (Vz/F)
Time frame: Day0-Day3 ( Predose ~ post-dose 48h)
Pharmacodynamic (PD) parameters
Time frame: through study completion, an average of 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention1: FXR0906 injection and Intervention2: FXR0906 injection in people with Healthy Adult Volunteers, run by Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yida Tang, PhD (+86 13901010211, tang_yida@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: through study completion, an average of 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.