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The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.
This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects.
Part A is a single ascending dose study of VB19055 tablets in healthy Chinese adult participants. Part B is a randomized, single-dose, two-period, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of VB19055 tablets in healthy Chinese adult participants.Part C is a multiple ascending dose study of VB19055 tablets in healthy Chinese adult participants.
Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Doses (SAD, Part A) | Experimental | In this part, 5 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 3:1 ratio to receive either VB19055 or placebo. |
|
| Food Effect (FE, Part B) | Experimental | 14 participants and single dose food effect cohort. This part is open-label, two sequence, two-period, crossover design. |
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| Single Ascending Doses (MAD,Part C) | Experimental | In this part, 4 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in an 3:1ratio to receive either VB19055 or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB19055 | Drug | In this part, VB19055 tablets will be administered as a single or multiple oral dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0 | The rate of Adverse events occur during the whole study | Average half a month |
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Inclusion Criteria:
For males: Agree to use effective contraception (specific methods detailed in Appendix 5) during the study and for 3 months after the last dose.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Song | Contact | China 86+18503817651 | songjia@vybio.com | |
| Xiaoqi Cao | Contact | China 86+15238088632 | caoxiaoqi@vybio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiguang Wang | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| VB19055 placebo | Drug | In this part, VB19055 placebo tablets will be administered as a single or multiple oral dose. |
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| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | 200025 | China |
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