CDI-988 Safety Study in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977140
• Other study ID #: CDI-988-P1-001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 27, 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Cocrystal Pharma, Inc.
• Contact: Sam Lee, PhD
• Phone: 425-750-7208
• Email: slee[@]cocrystalpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CDI-988
SARS-CoV-2 3CL protease inhibitor
• Placebo
matching placebo

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
Cocrystal Pharma, Inc.	Beyond Drug Development Pty Ltd., Cocrystal Pharma Australia Pty Ltd., Nucleus Network Pty Ltd., Resolutum Global Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	number of participants with treatment-emergent adverse events	Day 1 to 7 days after last dose
Primary	Laboratory abnormalities	number of participants with clinically significant laboratory abnormalities	Day 1 to 7 days after last dose
Primary	Vital signs	number of participants with clinically significant changes from baseline in vital signs	Day 1 to 7 days after last dose
Primary	ECGs	number of participants with clinically significant changes from baseline in ECGs	Day 1 to 7 days after last dose
Secondary	Maximum plasma concentration (Cmax)		Day 1 to 3 days after last dose
Secondary	Time of maximum plasma concentration (Tmax)		Day 1 to 7 days after last dose
Secondary	Area under the plasma concentration-time curve (AUC)		Day 1 to 3 days after last dose
Secondary	Elimination rate constant (lambda Z)		Day 1 to 3 days after last dose
Secondary	Terminal elimination half-life (t1/2)		Day 1 to 3 days after last dose