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

NCT07309042 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Atherosclerotic Cardiovascular Diseases
  • Cerebrovascular Diseases

Interventions

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.

Sponsors & Collaborators

  • Beijing Inno Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Teresa Chen, Master · Beijing Inno Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-02-28
Completion
2026-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309042 on ClinicalTrials.gov