CC-42344 Safety Study in Healthy Participants

Sponsor

Cocrystal Pharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05202379

Collaborator

Cocrystal Pharma Australia Pty Ltd. (Other), Linear Clinical Research (Industry)

Enrollment

Location

Arms

6.6

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.

Condition or Disease	Intervention/Treatment	Phase
Influenza A	Drug: CC-42344 Drug: Placebo	Phase 1

Detailed Description

This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.

Up to 56 healthy men or women aged between 18-55 will be enrolled in this study in two parts.

Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine.

Part 2: will involve a multiple-ascending dose (MAD) where 24 participants (3 groups of 8) will be randomised to receive an oral dose of study drug or placebo given once a day for 14 days. The placebo will look the same as the study drug but will not contain any medicine.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

4 cohorts for SAD, with food cohort; 3 cohorts for MAD; 6 active and 2 placebo per cohort4 cohorts for SAD, with food cohort; 3 cohorts for MAD; 6 active and 2 placebo per cohort

Masking:

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

Masking Description:

active and placebo capsules identical visually.

Primary Purpose:

Other

Official Title:

A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of the Influenza A Virus Replication Inhibitor CC-42344

Actual Study Start Date :

Feb 11, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAD cohort 1A first dose level with 6 active and 2 placebo healthy participants	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules
Experimental: SAD cohort 1B second dose level with 6 active and 2 placebo healthy participants	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules
Experimental: SAD cohort 1C third dose level with 6 active and 2 placebo healthy participants; food-effect cohort	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules
Experimental: SAD cohort 1D fourth dose level with 6 active and 2 placebo healthy participants	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules
Experimental: MAD cohort 2A first dose level with 6 active and 2 placebo healthy participants dose x 14 days	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules
Experimental: MAD cohort 2B second dose level with 6 active and 2 placebo healthy participants dose x 14 days	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules
Experimental: MAD cohort 3B third dose level with 6 active and 2 placebo healthy participants dose x 14 days	Drug: CC-42344 CC-42344 capsules Other Names: Active Drug: Placebo Placebo capsules

Outcome Measures

Primary Outcome Measures

treatment emergent adverse events [Day 1 to Day 21]
number of participants with treatment-emergent adverse events
laboratory abnormalities [Day 1 to Day 21]
number of participants with clinically significant laboratory abnormalities
vital signs [Day 1 to Day 21]
number of participants with clinically significant changes from baseline in vital signs
ECG [Day 1 to Day 14]
number of participants with clinically significant changes from baseline in ECGs

Secondary Outcome Measures

maximum plasma concentration [Day 1 to Day 14]
measurement of maximum plasma concentration (Cmax)
time of maximum plasma concentration [Day 1 to Day 14]
measurement of time of maximum plasma concentration (Tmax)
area under the plasma concentration-time curve [Day 1 to Day 14]
measurement of area under the plasma concentration-time curve (AUC)
elimination rate constant [Day 1 to Day 11]
measurement of elimination rate constant
terminal elimination half-life [Day 1 to Day 11]
measurement of terminal elimination half-life (t1/2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria (main):

Healthy males or healthy, non-pregnant, non-lactating females
Body weight of at least 50 kg
Body mass index between ≥18.0 and ≤32.0 kg/m2
Good state of health (mentally and physically)
Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy

Exclusion Criteria (main):

Have received any investigational drug in a clinical research study within the previous 30 days before screening
Have received a coronavirus disease 2019 (COVID-19) vaccine within 2 weeks prior to randomization
History of any drug or alcohol abuse in the past 2 years
Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study
Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linear Clinical Research	Nedlands	Western Australia	Australia	6009

Sponsors and Collaborators

Cocrystal Pharma, Inc.
Cocrystal Pharma Australia Pty Ltd.
Linear Clinical Research

Investigators

Principal Investigator: Sam Salman, MD, Linear Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cocrystal Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT05202379

Other Study ID Numbers:

CC-42344-P1-001

First Posted:

Jan 21, 2022

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

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:

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Mar 10, 2022