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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

BSA204
Drug
BSA204 Injection
Placebo
Drug
Placebo

Treatment groups

40 Participants

are divided into 5 treatment groups

Group A: Cohort1Experimental treatment 2 interventions

Group B: Cohort2Experimental treatment 2 interventions

Group C: Cohort3Experimental treatment 2 interventions

Group D: Cohort4Experimental treatment 2 interventions

Group E: Cohort5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame

From the time of dosing on Day 1 through Day180

Secondary outcomes

Percent change from Baseline in serum LDL-C and Lp(a) at Day 180

Time frame

From the time of dosing on Day 1 through Day 180

Sponsors and contacts

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

Bisirna Therapeutics (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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