Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652297
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2020-11-16
Brief Title:
Safety Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Randomized Double-blind Placebo-controlled Dose Escalation Trial to Assess the Safety Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administration of HS-10356 in healthy volunteers
Detailed Description:
This is a phase I randomized double-blind placebo-controlled single ascending dose SAD and multiple ascending dose MAD clinical trial to assess the safety tolerability and pharmacokinetics of HS-10356 oral formulation in Chinese healthy adult volunteers
Approximately five sequential dose panels single oral doses of 26153045mg HS-10356 will be evaluated in SAD To protect the safety of volunteers two sentinel volunteers were first enrolled in the first dose panel 2mg panel and randomly assigned to HS-10356 or placebo in a 11 ratio After the sentinel volunteers were given the dose for at least 24 hours and confirmed that they were safe the remaining 6 volunteers were randomly assigned to HS-10356 or placebo in a ratio of 51 For the follow-up panels of SAD volunteers were randomly assigned to either the experimental group or the placebo group 6 cases in HS-10356 and 2 cases in placebo in a 31 ratio using block randomization method Approximately three sequential dose panels 14 consecutive days for respectively daily oral doses of 61530mg HS-10356 QD will be evaluated in MAD Volunteers were randomly assigned to either the experimental group or the placebo group 9 cases in the HS-10356 and 3 cases in the placebo in a ratio of 31 using block randomization method Each subject will receive only one regimen in this study Safety data up to Day12 2 in SAD and up to Day25 2 in MAD will be reviewed prior to dose escalation Cohorts of SAD and MAD will be added or removed depending on the assessment results of SRC
Approximately five sequential dose panels single oral doses of 26153045mg HS-10356 will be evaluated in SAD To protect the safety of volunteers two sentinel volunteers were first enrolled in the first dose panel 2mg panel and randomly assigned to HS-10356 or placebo in a 11 ratio After the sentinel volunteers were given the dose for at least 24 hours and confirmed that they were safe the remaining 6 volunteers were randomly assigned to HS-10356 or placebo in a ratio of 51 For the follow-up panels of SAD volunteers were randomly assigned to either the experimental group or the placebo group 6 cases in HS-10356 and 2 cases in placebo in a 31 ratio using block randomization method Approximately three sequential dose panels 14 consecutive days for respectively daily oral doses of 61530mg HS-10356 QD will be evaluated in MAD Volunteers were randomly assigned to either the experimental group or the placebo group 9 cases in the HS-10356 and 3 cases in the placebo in a ratio of 31 using block randomization method Each subject will receive only one regimen in this study Safety data up to Day12 2 in SAD and up to Day25 2 in MAD will be reviewed prior to dose escalation Cohorts of SAD and MAD will be added or removed depending on the assessment results of SRC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None