Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2023-09-27
2025-07-23
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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SAD Cohort 1A
first single-dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
SAD Cohort 1B
second single-dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
SAD Cohort 1C
third single-dose level; food-effect cohort
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
SAD Cohort 1D
fourth single-dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
MAD Cohort 2A
first multiple-dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
MAD Cohort 2B
second multiple-dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
MAD Cohort 2C
third multiple-dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
SAD Cohort 1E
fifth dose level; food effect cohort
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
SAD Cohort 1F
sixth dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
MAD Cohort 2D
4th multiple dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
MAD Cohort 2E
5th multiple dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
MAD Cohort 2F
6th multiple dose level
CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
Interventions
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CDI-988
SARS-CoV-2 3CL protease inhibitor
Placebo
matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
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Cocrystal Pharma Australia Pty Ltd.
UNKNOWN
Beyond Drug Development Pty Ltd.
UNKNOWN
Resolutum Global Pty Ltd.
UNKNOWN
Scientia Clinical Research Pty Ltd
UNKNOWN
Cocrystal Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Argent, MD
Role: PRINCIPAL_INVESTIGATOR
Scientia Clinical Research
Locations
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Scientia Clinical Research Pty Ltd
Randwick, New South Wales, Australia
Countries
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Other Identifiers
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CDI-988-P1-001
Identifier Type: -
Identifier Source: org_study_id
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