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| Name | Class |
|---|---|
| Cocrystal Pharma Australia Pty Ltd. | UNKNOWN |
| Beyond Drug Development Pty Ltd. | UNKNOWN |
| Resolutum Global Pty Ltd. | UNKNOWN |
| Scientia Clinical Research Pty Ltd |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1A | Experimental | first single-dose level |
|
| SAD Cohort 1B | Experimental | second single-dose level |
|
| SAD Cohort 1C | Experimental | third single-dose level; food-effect cohort |
|
| SAD Cohort 1D | Experimental | fourth single-dose level |
|
| MAD Cohort 2A | Experimental | first multiple-dose level |
|
| MAD Cohort 2B | Experimental | second multiple-dose level |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDI-988 | Drug | SARS-CoV-2 3CL protease inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | number of participants with treatment-emergent adverse events | Day 1 to 7 days after last dose |
| Laboratory abnormalities | number of participants with clinically significant laboratory abnormalities | Day 1 to 7 days after last dose |
| Vital signs | number of participants with clinically significant changes from baseline in vital signs | Day 1 to 7 days after last dose |
| ECGs | number of participants with clinically significant changes from baseline in ECGs | Day 1 to 7 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Day 1 to 3 days after last dose | |
| Time of maximum plasma concentration (Tmax) | Day 1 to 7 days after last dose | |
| Area under the plasma concentration-time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Argent, MD | Scientia Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Pty Ltd | Randwick | New South Wales | 2031 | Australia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2026 | |
| Reset | May 18, 2026 | |
| Release | Jun 1, 2026 | |
| Reset | Jun 24, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2026 | May 18, 2026 | |||
| Jun 1, 2026 |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| UNKNOWN |
Part 1: 5 randomized single ascending dose cohorts of 8 participants and 1 open-label single ascending dose cohort of 6 participants. In Part 2, 6 multiple ascending dose cohorts, each with 8 participants
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| MAD Cohort 2C | Experimental | third multiple-dose level |
|
| SAD Cohort 1E | Experimental | fifth dose level; food effect cohort |
|
| SAD Cohort 1F | Experimental | sixth dose level |
|
| MAD Cohort 2D | Experimental | 4th multiple dose level |
|
| MAD Cohort 2E | Experimental | 5th multiple dose level |
|
| MAD Cohort 2F | Experimental | 6th multiple dose level |
|
| Placebo | Drug | matching placebo |
|
| Day 1 to 3 days after last dose |
| Elimination rate constant (lambda Z) | Day 1 to 3 days after last dose |
| Terminal elimination half-life (t1/2) | Day 1 to 3 days after last dose |
| Jun 24, 2026 |
| Jun 28, 2026 |
| D007239 |
| Infections |