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

ConditionHealthy Adult Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention1: FXR0906 injection

    Drug

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

  • Intervention2: FXR0906 injection

    Drug

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

  • Placebo

    Drug

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

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Arm1: FXR0906 injectionExperimental treatment 1 intervention
Group B: Arm2: FXR0906 injectionExperimental treatment 1 intervention
Group C: Arm3: placebo comparator: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

safety

the incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with FXR0906

Time frame
through study completion, an average of 26 weeks

Secondary outcomes

1

peak concentration (Cmax)

PK parameters

Time frame
Day0-Day3 ( Predose ~ post-dose 48h)
2

time to peak (Tmax)

PK parameter

Time frame
Day0-Day3 ( Predose ~ post-dose 48h)
3

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

PK parameter

Time frame
Day0-Day3 ( Predose ~ post-dose 48h)
4

area under the blood drug concentration-time curve from 0 to the last measurable blood drug concentration time t (AUC0-t)

PK parameter

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: