Lipids & metabolic liver disease
Safety, pharmacokinetics and pharmacodynamics of Plozasiran in Chinese healthy volunteers
Authors' conclusion
Plozasiran at 25 and 50 mg was well tolerated with acceptable safety profile in Chinese HVs. Safety, PK and PD profiles observed in the present study were consistent with the data reported from clinical studies conducted outside China.
Study context
- Population
- Chinese adult healthy volunteers
- Participants
- 24 volunteers
- Comparison
- Single subcutaneous (SC) plozasiran 25 mg or 50 mg vs placebo
- 25 mgn = 9
- 50 mgn = 9
- Placebon = 6reference
- Primary endpoint
- Safety, tolerability, pharmacokinetics (PK) and PD profiles
- Follow-up
- 85 days
Methodological detailsdouble-blind, placebo-controlled, phase I
- Double-blind
- Placebo-controlled
- Phase I
Primary result
As reported in the abstract
Safety, tolerability, PK and PD
- Max geomean serum concentration, 25 mg (CV% 36.4%)
- 102 ng/mL
- Max geomean serum concentration, 50 mg (CV% 58.1%)
- 216 ng/mL
- Median Tmax, 25 mg (2.00, 6.02)
- 3 h
- Median Tmax, 50 mg (1.00, 6.00)
- 6 h
- Geomean AUC0-t, 25 mg (21.1%)
- 971 ng*h/mL
- Geomean AUC0-t, 50 mg (29.5%)
- 2016 ng*h/mL
- AUC0-∞, 25 mg (20.80%)
- 999 ng*h/mL
- AUC0-∞, 50 mg (27.0%)
- 2148 ng*h/mL
- Geomean CL/F, 25 mg (20.80%)
- 25.0 L/h
- Geomean CL/F, 50 mg (27.0%)
- 23.3 L/h
- Geomean Vz/F, 25 mg (41.8%)
- 120 L
- Geomean Vz/F, 50 mg (41.8%)
- 100 L
- Geomean t1/2, 25 mg (27.0%)
- 3.33 h
- Geomean t1/2, 50 mg (22.0%)
- 2.99 h
- Max mean decrease in Apolipoprotein C3 (APOC3) from baseline at day 29, 25 mg
- 79.0%
- Max mean decrease in APOC3 from baseline at day 29, 50 mg
- 95.1%
- Corresponding triglyceride (TG) reduction, 25 mg
- 64.5%
- Corresponding TG reduction, 50 mg
- 71.3%
Further findings
Other lipids
- Increase in HDL-C and decreases in non-HDL-C, ApoB, LDL-C and VLDL-C with plozasiran
Safety
- Treatment-emergent adverse events (TEAEs), plozasiran
- 9 of 18
- TEAEs, placebo
- 1 of 6
- Deaths, severe AEs or TEAEs leading to discontinuation
- 0
- Subjects needing concomitant medications for TEAEs (4 TEAEs), plozasiran
- 2
- All other TEAEs transient and recovered autonomously
Original publication
Safety, pharmacokinetics and pharmacodynamics of Plozasiran in Chinese healthy volunteers. Cardiovasc Diabetol. Published 15 October 2025. doi:10.
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