CDI-988 Safety Study in Healthy Participants

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cocrystal Pharma, Inc.
• Collaborators: Beyond Drug Development Pty Ltd.; Cocrystal Pharma Australia Pty Ltd.; Nucleus Network Pty Ltd.; Resolutum Global Pty Ltd.

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