CDI-988 Safety Study in Healthy Participants

Cocrystal Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: CDI-988

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05977140

CDI-988-P1-001

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 116 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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116 participants in 12 patient groups

SAD Cohort 1A

Experimental group

Description:

first single-dose level

Treatment:

Drug: CDI-988

Drug: Placebo

SAD Cohort 1B

Experimental group

Description:

second single-dose level

Treatment:

Drug: CDI-988

Drug: Placebo

SAD Cohort 1C

Experimental group

Description:

third single-dose level; food-effect cohort

Treatment:

Drug: CDI-988

Drug: Placebo

SAD Cohort 1D

Experimental group

Description:

fourth single-dose level

Treatment:

Drug: CDI-988

Drug: Placebo

MAD Cohort 2A

Experimental group

Description:

first multiple-dose level

Treatment:

Drug: CDI-988

Drug: Placebo

MAD Cohort 2B

Experimental group

Description:

second multiple-dose level

Treatment:

Drug: CDI-988

Drug: Placebo

MAD Cohort 2C

Experimental group

Description:

third multiple-dose level

Treatment:

Drug: CDI-988

Drug: Placebo

SAD Cohort 1E

Experimental group

Description:

fifth dose level; food effect cohort

Treatment:

Drug: CDI-988

Drug: Placebo

SAD Cohort 1F

Experimental group

Description:

sixth dose level

Treatment:

Drug: CDI-988

Drug: Placebo

MAD Cohort 2D

Experimental group

Description:

4th multiple dose level

Treatment:

Drug: CDI-988

Drug: Placebo

MAD Cohort 2E

Experimental group

Description:

5th multiple dose level

Treatment:

Drug: CDI-988

Drug: Placebo

MAD Cohort 2F

Experimental group

Description:

6th multiple dose level

Treatment:

Drug: CDI-988

Drug: Placebo