Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342713
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-26
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 1 Randomized Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This study is the first-in-human FIH study for BGB-45035 The study will evaluate the safety tolerability pharmacokinetics and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants
Study details include
The study duration will be up to 16 months
The treatment duration will be up to 14 days
Safety follow-up 30 days after last dose of study drug
Study details include
The study duration will be up to 16 months
The treatment duration will be up to 14 days
Safety follow-up 30 days after last dose of study drug
Detailed Description:
None
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