Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977140
Status:
RECRUITING
Last Update Posted:
2023-10-31
First Post:
2023-07-28
Brief Title:
CDI-988 Safety Study in Healthy Participants
Sponsor:
Cocrystal Pharma Inc
Organization:
Cocrystal Pharma Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-Blinded Placebo-Controlled First-in-Human Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of Oral CDI-988 in Healthy Adult Participants
Status:
RECRUITING
Status Verified Date:
2024-08
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 goal of this clinical trial is to learn about the safety and pharmacokinetics PK the amount of drug in the blood of a new drug called CDI-988 in healthy volunteers
The main questions it aims to answer are
Are there any side effects of the drug
What is the amount of drug that reaches the bloodstream Participants will be assigned by chance to take either CDI-988 or placebo by mouth and have physical exams electrocardiograms ECGs vital signs and blood tests to look for any side effects
The main questions it aims to answer are
Are there any side effects of the drug
What is the amount of drug that reaches the bloodstream Participants will be assigned by chance to take either CDI-988 or placebo by mouth and have physical exams electrocardiograms ECGs vital signs and blood tests to look for any side effects
Detailed Description:
CDI-988 is a severe acute respiratory syndrome coronavirus-2 SARS-CoV-2 3-chymotrypsin-like 3CL protease inhibitor for oral administration This study is being conducted in 2 parts to examine the safety tolerability and PK of CDI-988 in healthy participants Part 1 will entail escalating single doses in sequential cohorts and Part 2 will enroll escalating multiple-dose cohorts Participants will be monitored for adverse events vital signs laboratory values and electrocardiograms ECGs
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