CDI-988 Safety Study in Healthy Participants
- Conditions
- Healthy Volunteers
- Interventions
- Drug: CDI-988Drug: Placebo
- 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
- 70
- 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 1f CDI-988 sixth dose level SAD Cohort 1f Placebo sixth dose level MAD Cohort 2A CDI-988 first multiple-dose level MAD Cohort 2A Placebo first multiple-dose level MAD Cohort 2B CDI-988 second 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 CDI-988 fifth dose level; food effect cohort SAD Cohort 1D CDI-988 fourth single-dose level SAD Cohort 1D Placebo fourth single-dose level SAD Cohort 1A CDI-988 first single-dose level SAD Cohort 1A Placebo first single-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
- 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