CDI-988 Safety Study in Healthy Participants

Last updated: April 10, 2025
Sponsor: Cocrystal Pharma, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

CDI-988

Clinical Study ID

NCT05977140
CDI-988-P1-001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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, urinalysistest results

  • Clinically significant abnormal ECG or vital signs

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 27, 2023
Estimated Completion Date:
June 30, 2025

Study 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).

Connect with a study center

  • Scientia Clinical Research Pty Ltd

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Nucleus Network Pty Ltd

    Melbourne, Victoria 3004
    Australia

    Site Not Available

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