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NCT Number: NCT05977140

CDI-988 Safety Study in Healthy Participants

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.

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Key information

Conditions

Healthy Volunteers Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Research Pty Ltd

Randwick, New South Wales, 2031, Australia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDI-988

Drug

SARS-CoV-2 3CL protease inhibitor

Placebo

Drug

matching placebo

Primary outcomes

  1. Adverse events

    Time frame: Day 1 to 7 days after last dose

    number of participants with treatment-emergent adverse events

  2. Laboratory abnormalities

    Time frame: Day 1 to 7 days after last dose

    number of participants with clinically significant laboratory abnormalities

  3. Vital signs

    Time frame: Day 1 to 7 days after last dose

    number of participants with clinically significant changes from baseline in vital signs

  4. ECGs

    Time frame: Day 1 to 7 days after last dose

    number of participants with clinically significant changes from baseline in ECGs

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Day 1 to 3 days after last dose

  2. Time of maximum plasma concentration (Tmax)

    Time frame: Day 1 to 7 days after last dose

  3. Area under the plasma concentration-time curve (AUC)

    Time frame: Day 1 to 3 days after last dose

  4. Elimination rate constant (lambda Z)

    Time frame: Day 1 to 3 days after last dose

  5. Terminal elimination half-life (t1/2)

    Time frame: Day 1 to 3 days after last dose

Sponsors and collaborators

Lead sponsor

Cocrystal Pharma, Inc.

Industry

Collaborators

  • Beyond Drug Development Pty Ltd.
  • Cocrystal Pharma Australia Pty Ltd.
  • Resolutum Global Pty Ltd.
  • Scientia Clinical Research Pty Ltd

Registry information

Official study title

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of Oral CDI-988 in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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