NCT07309042

Phase 1 Study of the Safety and Pharmacokinetics of YN001 With Rosuvastatin in Healthy Chinese Subjects

A Randomized, Open-label Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of the Combination of YN001 and Oral Rosuvastatin Calcium Tablets in Healthy Chinese Individuals

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Beijing Inno Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to investigate the safety and tolerability of YN001 in combination with rosuvastatin, so as to provide evidence for the feasibility of YN001 combined with statins in subsequent clinical trials.

Detailed description

The primary objective of this study is to generate the evidence on the safety, tolerability and pharmacokinetic (PK) interaction profile of YN001 when combined with rosuvastatin, a widely prescribed high-intensity statin. YN001 is being developed for patients with atherosclerotic cardiovascular disease (ASCVD) or at high cardiovascular risk. In these populations, contemporary treatment guidelines recommend statin therapy as foundational background treatment. However, because the human safety and PK profile of YN001 in combination with statins have not yet been established, concomitant statin use has been prohibited in all completed, ongoing, and planned YN001 clinical trials. This restriction creates a clinically and regulatorily important evidence gap: for YN001 to be used in its intended population, it is essential to determine whether co-administration with rosuvastatin is safe and whether either drug's systemic exposure is meaningfully altered. To address this gap, the present study is designed as a single-centre, randomised, open-label, 3-sequence, 3-period crossover trial in healthy volunteers. The study will evaluate the the safety, tolerability and pharmacokinetics of repeated-dose intravenous YN001 administered alone and in combination with oral rosuvastatin calcium. A total of 24 subjects will be enrolled. After screening, eligible participants will be randomly allocated 1:1:1 to three cohorts (8 per cohort, target 1:1 sex ratio). Each cohort will undergo three 14-day treatment periods separated by a 7-day wash-out (permissible window ±7 days). The results of this study will inform whether concomitant statin can be safely permitted in subsequent Phase II and Phase III YN001 clinical trials, thereby enabling evaluation of YN001 in the intended ASCVD and high-cardiovascular-risk populations for whom chronic statin therapy is standard of care.

Conditions

• Atherosclerotic Cardiovascular Diseases
• Cerebrovascular Diseases

Interventions

Type	Name	Description
DRUG	YN001, Rosuvastatin calcium Tablets	Cycle 1 (Day 1 to day 14) : YN001, 40 mg, once a week, intravenous infusion, administered on day 1 and day 8, for a total of 2 doses. Cycle 2 (days 22 to 35) : YN001, 40 mg, once a week, intravenous infusion, administration on days 22 and 29, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 3 (Days 43 to 56) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally.
DRUG	YN001, Rosuvastatin calcium Tablets	Cycle 1 (Day 1 to day 14) : YN001, 40 mg, once a week, intravenous infusion, administered on day 1 and day 8, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, oral administration. Cycle 2 (Days 22 to 35) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 3 (days 43 to 56) : YN001, 40 mg, once a week, intravenous infusion, administration of D43 and D50, for a total of two doses.
DRUG	YN001, Rosuvastatin calcium Tablets	Cycle 1 (Day 1 to day 14) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 2 (Days 22 to 35) : YN001, 40 mg, once a week, intravenous infusion. Cycle 3 (days 43 to 56) : YN001, 40 mg, once a week, intravenous infusion, administration of D43 and D50, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, oral administration.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-12-30
• Last updated: 2025-12-30