CDI-988 Safety Study in Healthy Participants

Study Overview
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Brief Summary
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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: 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.

Detailed Description
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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).

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CDI-988
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 4 single-ascending-dose (SAD) cohorts, including food-effect cohort 3 multiple-ascending-dose (MAD) cohorts 8 participants per cohort (6 active and 2 placebo)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD Cohort 1A<br>first single-dose level | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|
| Experimental: SAD Cohort 1B<br>second single-dose level | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|
| Experimental: SAD Cohort 1C<br>third single-dose level; food-effect cohort | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|
| Experimental: SAD Cohort 1D<br>fourth single-dose level | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|
| Experimental: MAD Cohort 2A<br>first multiple-dose level | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|
| Experimental: MAD Cohort 2B<br>second multiple-dose level | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|
| Experimental: MAD Cohort 2C<br>third multiple-dose level | Drug: CDI-988<br>* SARS-CoV-2 3CL protease inhibitor<br>Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, SARS-CoV-2