CDI-988 Safety Study in Healthy Participants

PHASE1RECRUITING

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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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-09-27

    Primary completion: 2024-11-01

    Study completion finish: 2024-11-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05977140

    Intervention or treatment

    DRUG: CDI-988

    DRUG: Placebo

    Conditions

    • Healthy Volunteers

    Find a site

    Closest Location:

    Scientia Clinical Research Pty Ltd

    Research sites nearby

    Select from list below to view details:

    • Scientia Clinical Research Pty Ltd

      Randwick, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: SAD Cohort 1A
    • first single-dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: SAD Cohort 1B
    • second single-dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: SAD Cohort 1C
    • third single-dose level; food-effect cohort
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: SAD Cohort 1D
    • fourth single-dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: MAD Cohort 2A
    • first multiple-dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: MAD Cohort 2B
    • second multiple-dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: MAD Cohort 2C
    • third multiple-dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: SAD Cohort 1e
    • fifth dose level; food effect cohort
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor
    EXPERIMENTAL: SAD Cohort 1f
    • sixth dose level
    DRUG: CDI-988
    • SARS-CoV-2 3CL protease inhibitor

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Adverse eventsnumber of participants with treatment-emergent adverse eventsDay 1 to 7 days after last dose
    Laboratory abnormalitiesnumber of participants with clinically significant laboratory abnormalitiesDay 1 to 7 days after last dose
    Vital signsnumber of participants with clinically significant changes from baseline in vital signsDay 1 to 7 days after last dose
    ECGsnumber of participants with clinically significant changes from baseline in ECGsDay 1 to 7 days after last dose

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Maximum plasma concentration (Cmax)Not SpecifiedDay 1 to 3 days after last dose
    Time of maximum plasma concentration (Tmax)Not SpecifiedDay 1 to 7 days after last dose
    Area under the plasma concentration-time curve (AUC)Not SpecifiedDay 1 to 3 days after last dose
    Elimination rate constant (lambda Z)Not SpecifiedDay 1 to 3 days after last dose
    Terminal elimination half-life (t1/2)Not SpecifiedDay 1 to 3 days after last dose

    Frequently Asked Questions

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    References

    Clinical Trials Gov: CDI-988 Safety Study in Healthy Participants

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