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

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

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

Treatments tested in this trial

  • Intervention1: FXR0906 injection
  • Intervention2: FXR0906 injection
  • Placebo

Treatment groups

24 Participants
are divided into 3 treatment groups