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CC-42344 Safety Study in Healthy Participants

Primary Purpose

Influenza A

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

CC-42344

Placebo

About this trial

This is an interventional other trial for Influenza A

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Linear Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

SAD cohort 1A

SAD cohort 1B

SAD cohort 1C

SAD cohort 1D

MAD cohort 2A

MAD cohort 2B

MAD cohort 2C

MAD cohort 2D

MAD cohort 2E

Arm Description

first dose level with 6 active and 2 placebo healthy participants

second dose level with 6 active and 2 placebo healthy participants

third dose level with 12 active and 2 placebo healthy participants; food-effect cohort

fourth dose level with 6 active and 2 placebo healthy participants

first dose level with 6 active and 2 placebo healthy participants dose x 14 days

second dose level with 6 active and 2 placebo healthy participants dose x 14 days

third dose level with 6 active and 2 placebo healthy participants dose x 14 days

forth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Outcomes

Primary Outcome Measures

treatment emergent adverse events

number of participants with treatment-emergent adverse events

laboratory abnormalities

number of participants with clinically significant laboratory abnormalities

vital signs

number of participants with clinically significant changes from baseline in vital signs

ECG

number of participants with clinically significant changes from baseline in ECGs

Secondary Outcome Measures

maximum plasma concentration

measurement of maximum plasma concentration (Cmax)

time of maximum plasma concentration

measurement of time of maximum plasma concentration (Tmax)

area under the plasma concentration-time curve

measurement of area under the plasma concentration-time curve (AUC)

elimination rate constant

measurement of elimination rate constant

terminal elimination half-life

measurement of terminal elimination half-life (t1/2)

Full Information

NCT ID

NCT05202379

First Posted

January 10, 2022

Last Updated

May 29, 2023

Sponsor

Cocrystal Pharma, Inc.

Collaborators

Cocrystal Pharma Australia Pty Ltd., Linear Clinical Research

1. Study Identification

Unique Protocol Identification Number

NCT05202379

Brief Title

CC-42344 Safety Study in Healthy Participants

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 11, 2022 (Actual)

Primary Completion Date

March 29, 2023 (Actual)

Study Completion Date

March 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cocrystal Pharma, Inc.

Collaborators

Cocrystal Pharma Australia Pty Ltd., Linear Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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 78 healthy men or women aged between 18-55 are planned to 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. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug. Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza A

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

4 cohorts for SAD, with food cohort; 5 cohorts for MAD; 6 active and 2 placebo per cohort; 6 additional active in food cohort

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

active and placebo capsules identical visually.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAD cohort 1A

Arm Type

Experimental

Arm Description

first dose level with 6 active and 2 placebo healthy participants

Arm Title

SAD cohort 1B

Arm Type

Experimental

Arm Description

second dose level with 6 active and 2 placebo healthy participants

Arm Title

SAD cohort 1C

Arm Type

Experimental

Arm Description

third dose level with 12 active and 2 placebo healthy participants; food-effect cohort

Arm Title

SAD cohort 1D

Arm Type

Experimental

Arm Description

fourth dose level with 6 active and 2 placebo healthy participants

Arm Title

MAD cohort 2A

Arm Type

Experimental

Arm Description

first dose level with 6 active and 2 placebo healthy participants dose x 14 days

Arm Title

MAD cohort 2B

Arm Type

Experimental

Arm Description

second dose level with 6 active and 2 placebo healthy participants dose x 14 days

Arm Title

MAD cohort 2C

Arm Type

Experimental

Arm Description

third dose level with 6 active and 2 placebo healthy participants dose x 14 days

Arm Title

MAD cohort 2D

Arm Type

Experimental

Arm Description

forth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Arm Title

MAD cohort 2E

Arm Type

Experimental

Arm Description

forth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Intervention Type

Drug

Intervention Name(s)

CC-42344

Other Intervention Name(s)

Active

Intervention Description

CC-42344 capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules

Primary Outcome Measure Information:

Title

treatment emergent adverse events

Description

number of participants with treatment-emergent adverse events

Time Frame

Day 1 to 7 days after last dose

Title

laboratory abnormalities

Description

number of participants with clinically significant laboratory abnormalities

Time Frame

Day 1 to 7 days after last dose

Title

vital signs

Description

number of participants with clinically significant changes from baseline in vital signs

Time Frame

Day 1 to 7 days after last dose

Title

ECG

Description

number of participants with clinically significant changes from baseline in ECGs

Time Frame

Day 1 to 7 days after last dose

Secondary Outcome Measure Information:

Title

maximum plasma concentration

Description

measurement of maximum plasma concentration (Cmax)

Time Frame

Day 1 to 7 days after last dose

Title

time of maximum plasma concentration

Description

measurement of time of maximum plasma concentration (Tmax)

Time Frame

Day 1 to 7 days after last dose

Title

area under the plasma concentration-time curve

Description

measurement of area under the plasma concentration-time curve (AUC)

Time Frame

Day 1 to 7 days after last dose

Title

elimination rate constant

Description

measurement of elimination rate constant

Time Frame

Day 1 to 7 days after last dose

Title

terminal elimination half-life

Description

measurement of terminal elimination half-life (t1/2)

Time Frame

Day 1 to 7 days after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 any vaccine within 7 days 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam Salman, MD

Organizational Affiliation

Linear Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Linear Clinical Research

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

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CC-42344 Safety Study in Healthy Participants

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