CDI-988 Safety Study in Healthy Participants
- Registration Number
- NCT05977140
- Lead Sponsor
- Cocrystal Pharma, Inc.
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SAD Cohort 1A CDI-988 first single-dose level SAD Cohort 1A Placebo first single-dose level MAD Cohort 2A CDI-988 first multiple-dose level MAD Cohort 2A Placebo first multiple-dose level MAD Cohort 2B Placebo second multiple-dose level MAD Cohort 2C CDI-988 third multiple-dose level MAD Cohort 2C Placebo third multiple-dose level SAD Cohort 1E Placebo fifth dose level; food effect cohort MAD Cohort 2D CDI-988 4th multiple dose level SAD Cohort 1B CDI-988 second single-dose level SAD Cohort 1B Placebo second single-dose level SAD Cohort 1C CDI-988 third single-dose level; food-effect cohort SAD Cohort 1C Placebo third single-dose level; food-effect cohort SAD Cohort 1D CDI-988 fourth single-dose level SAD Cohort 1D Placebo fourth single-dose level MAD Cohort 2B CDI-988 second multiple-dose level SAD Cohort 1E CDI-988 fifth dose level; food effect cohort SAD Cohort 1F CDI-988 sixth dose level MAD Cohort 2D Placebo 4th multiple dose level MAD Cohort 2E Placebo 5th multiple dose level SAD Cohort 1F Placebo sixth dose level MAD Cohort 2F CDI-988 6th multiple dose level MAD Cohort 2F Placebo 6th multiple dose level MAD Cohort 2E CDI-988 5th multiple dose level
- Primary Outcome Measures
Name Time Method Laboratory abnormalities Day 1 to 7 days after last dose number of participants with clinically significant laboratory abnormalities
Vital signs Day 1 to 7 days after last dose number of participants with clinically significant changes from baseline in vital signs
Adverse events Day 1 to 7 days after last dose number of participants with treatment-emergent adverse events
ECGs Day 1 to 7 days after last dose number of participants with clinically significant changes from baseline in ECGs
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC) Day 1 to 3 days after last dose Terminal elimination half-life (t1/2) Day 1 to 3 days after last dose Elimination rate constant (lambda Z) Day 1 to 3 days after last dose Maximum plasma concentration (Cmax) Day 1 to 3 days after last dose Time of maximum plasma concentration (Tmax) Day 1 to 7 days after last dose
Trial Locations
- Locations (1)
Scientia Clinical Research Pty Ltd
🇦🇺Randwick, New South Wales, Australia