Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:03 PM
Study NCT ID:
NCT02280434
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study Accessing the Safety and Tolerability of CBP-307
Sponsor:
Connect Biopharm LLC
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CBP-307 Following Oral Single and Multiple Escalating Dose Administration
Status:
COMPLETED
Status Verified Date:
2016-11
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 will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects.
Detailed Description:
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects. The study will have two parts: Part 1 will assess 5 dose levels of the drug in single dosing; and Part 2 will evaluate 3 dose levels in 28-day repeat dosing. The effect of food will also be evaluated in a single dosing study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: