Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06504043 | A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants | PHASE1 | ENROLLING BY_INVITATION | 30 | — | — | Sep 17, 2024 | Mar 31, 2025 | Mar 14, 2025 | 1 | China |
Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Experimental: cohort low dose HST101 | EXPERIMENTAL | HST101 single SC administration of 150 mg or placebo; |
| Experimental: cohort high dose HST101 | EXPERIMENTAL | HST101 single SC administration of 300 mg or placebo. |
| Name | Type | Description |
|---|---|---|
| HST101 | DRUG | HST101 is a novel anti-PCSK9 fusion protein |
Inclusion Criteria: * Men and women who are ≥18 and ≤55 years of age with elevated LDL-C Levels; * LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.9 mmol/L (190 mg/dL) and TG ≤ 2.83 mmol/L (250 mg/dL) who are not on a lipid-lowering therapy 30 days prior to screening; * Body mass index (BMI) ≥18 and≤28 kg/m...