Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360874
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-30
First Post:
2024-03-28
Brief Title:
A Study to Evaluate Safety Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
Sponsor:
Shenzhen NewDEL Biotech Co Ltd
Organization:
Shenzhen NewDEL Biotech Co Ltd
Study Overview
Official Title:
Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
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 purpose of this study is to evaluate Safety Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
Detailed Description:
This is a Phase 1 randomized double-blind placebo-controlled study aimed at evaluating the safety tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers and then evaluate food effects
The study will be conducted in three parts Part A-Single ascending dose SAD Part B-Multiple ascending dose MAD and Part C-Food Effect Each subject will be enrolled in only one cohort of either Parts A or B or C of the study to receive only one dose regimen during the study
The study will be conducted in three parts Part A-Single ascending dose SAD Part B-Multiple ascending dose MAD and Part C-Food Effect Each subject will be enrolled in only one cohort of either Parts A or B or C of the study to receive only one dose regimen during the study
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