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.
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).
Drug: CDI-988
SARS-CoV-2 3CL protease inhibitor
Drug: Placebo
matching placebo
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
Scientia Clinical Research Pty Ltd
Randwick 2208285, New South Wales 2155400, Australia
Christopher Argent, MD, Principal Investigator
Scientia Clinical Research