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Completed
NCT05977140
CDI-988 Safety Study in Healthy Participants
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 94
Sponsor: Cocrystal Pharma, Inc.
Location: Scientia Clinical Research Pty Ltd Randwick New South Wales
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05977140). StuddyBuddy aggregates publicly available trial information.