Status:
COMPLETED
CDI-988 Safety Study in Healthy Participants
Lead Sponsor:
Cocrystal Pharma, Inc.
Collaborating Sponsors:
Cocrystal Pharma Australia Pty Ltd.
Beyond Drug Development Pty Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- Healthy males or non-pregnant, non-lactating females
- Body weight of at least 45 kg.
- Body mass index ≥18.0 and ≤32.0 kg/m2
- Good state of mental and physical health
- Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
Exclusion
- Received an investigational drug within 30 days
- Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days
- Drug or alcohol abuse in the past 12 months
- Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test results
- Clinically significant abnormal ECG or vital signs
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2025
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05977140
Start Date
September 27 2023
End Date
July 23 2025
Last Update
August 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Scientia Clinical Research Pty Ltd
Randwick, New South Wales, Australia, 2031