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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.
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
PHASE1
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
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/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: SAD Cohort 1A
| DRUG: CDI-988
|
EXPERIMENTAL: SAD Cohort 1B
| DRUG: CDI-988
|
EXPERIMENTAL: SAD Cohort 1C
| DRUG: CDI-988
|
EXPERIMENTAL: SAD Cohort 1D
| DRUG: CDI-988
|
EXPERIMENTAL: MAD Cohort 2A
| DRUG: CDI-988
|
EXPERIMENTAL: MAD Cohort 2B
| DRUG: CDI-988
|
EXPERIMENTAL: MAD Cohort 2C
| DRUG: CDI-988
|
EXPERIMENTAL: SAD Cohort 1e
| DRUG: CDI-988
|
EXPERIMENTAL: SAD Cohort 1f
| DRUG: CDI-988
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Not Specified | Day 1 to 3 days after last dose |
| Time of maximum plasma concentration (Tmax) | Not Specified | Day 1 to 7 days after last dose |
| Area under the plasma concentration-time curve (AUC) | Not Specified | Day 1 to 3 days after last dose |
| Elimination rate constant (lambda Z) | Not Specified | Day 1 to 3 days after last dose |
| Terminal elimination half-life (t1/2) | Not Specified | Day 1 to 3 days after last dose |
Frequently Asked Questions
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