Safety, PK, and PD of BSA204 in Chinese Adults With Borderline Elevated Lipoprotein(a)

ConditionDyslipidemias
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBisirna Therapeutics (Suzhou) Co., Ltd.

About this trial

The purpose of this Phase 1 clinical study is to evaluate the safety and tolerability of a single dose of BSA204 injection in Chinese adults with borderline high levels of lipoprotein(a) \[Lp(a)\].

Eligibility criteria

Qualifiers

Body mass index (BMI) 18 to 30 kg/m2

Fasting triglycerides (TG) ≤ 4.5 mmol/L

Borderline elevated fasting lipoprotein(a) [Lp(a)] levels as defined in the protocol

Fasting low-density lipoprotein cholesterol (LDL-C) within the range specified for the assigned dose cohort

Disqualifiers

Pregnant or lactating women.

History or presence of significant medical conditions

Abnormal ECG findings, including a prolonged QTcF interval (> 450 msec for males or > 470 msec for females)

Prior treatment with small interfering RNA (siRNA) or antisense oligonucleotides within 12 months, or recent use of specific lipid-lowering therapies

Trial design

Treatments tested in this trial

  • BSA204
  • Placebo

Treatment groups

40 Participants
are divided into 5 treatment groups

Locations

2
Peking University First Hospital BeijingBeijing Municipality, China
Peking University First Hospital BeijingBeijing Municipality, China

Sponsors and collaborators

Bisirna Therapeutics (Suzhou) Co., Ltd.

Lead sponsor