CDI-988 Safety Study in Healthy Participants

Sponsor

Cocrystal Pharma, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05977140

Collaborator

Cocrystal Pharma Australia Pty Ltd. (Other), Nucleus Network Pty Ltd. (Other), Beyond Drug Development Pty Ltd. (Other), Resolutum Global Pty Ltd. (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: CDI-988 Drug: Placebo	Phase 1

Detailed 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention 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)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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Adverse events [Day 1 to 7 days after last dose]
number of participants with treatment-emergent adverse events
Laboratory abnormalities [Day 1 to 7 days after last dose]
number of participants with clinically significant laboratory abnormalities
Vital signs [Day 1 to 7 days after last dose]
number of participants with clinically significant changes from baseline in vital signs
ECGs [Day 1 to 7 days after last dose]
number of participants with clinically significant changes from baseline in ECGs

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network Pty Ltd	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Cocrystal Pharma, Inc.
Cocrystal Pharma Australia Pty Ltd.
Nucleus Network Pty Ltd.
Beyond Drug Development Pty Ltd.
Resolutum Global Pty Ltd.

Investigators

Principal Investigator: Philip Ryan, MD, PhD, Nucleus Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cocrystal Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT05977140

Other Study ID Numbers:

CDI-988-P1-001

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cocrystal Pharma, Inc.

Coronavirus

SARS-CoV-2

Study Results

No Results Posted as of Aug 4, 2023