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

ConditionsAtherosclerotic Cardiovascular DiseasesCerebrovascular Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeijing Inno Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Fully understand the purpose, characteristics, research methods and potential adverse reactions of this study, voluntarily participate in the study as a subject, and sign the Informed Consent Form (ICF) before any assessments are performed.

Healthy Chinese male and female subjects aged 18 to 55 years (inclusive, based on the age at the time of signing the ICF).

Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) ranging from 18 to 28 kg/m² (including the critical values).

Judged by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) and viral serological test results (normal or abnormal without clinical significance) to be in good general health.

Disqualifiers

Participation in other clinical trials within 3 months prior to the first dose or within 5 half-lives (whichever is longer). Subjects who withdrew from the study before receiving the study drug (i.e., not administered the drug) are eligible for enrollment.

Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 2 weeks prior to the first dose, or receipt of any type of vaccination.

Consumption of diets that may affect the in vivo metabolism of drugs (including grapefruit or grapefruit products, pitaya, mango, etc.) within 7 days prior to screening, engagement in strenuous exercise, or consumption of other diets that the investigator deems may affect the absorption, distribution, metabolism, or excretion of drugs.

History of severe food allergies (e.g., anaphylactic shock). Mild food allergies such as lactose intolerance and glucose intolerance are not excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • YN001, Rosuvastatin calcium Tablets

    Drug

    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.

  • YN001, Rosuvastatin calcium Tablets

    Drug

    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.

  • YN001, Rosuvastatin calcium Tablets

    Drug

    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.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: YN001Other 1 intervention
Group B: YN001+ Rosuvastatin calcium TabletsOther 1 intervention
Group C: Rosuvastatin calcium TabletsOther 1 intervention

Trial outcomes

Primary outcomes

1

The incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
84 days

Secondary outcomes

1

Plasma pharmacokinetics: Maximum plasma concentration (Cmax)

Time frame
63 days
2

Number of Participants With ADA

Time frame
63 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Beijing Inno Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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