## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** CC-42344-P1-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Cocrystal Pharma, Inc.
### Status Module
#### Completion Date
**Date:** 2023-03-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-03-29

**Type:** ACTUAL

#### Start Date
**Date:** 2022-02-11

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2022-01-21
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-10
**Study First Submit QC Date:** 2022-01-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Cocrystal Pharma Australia Pty Ltd.

**Class:** INDUSTRY

**Name:** Linear Clinical Research

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cocrystal Pharma, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Influenza A

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

**Intervention 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 Info

**Masking:** QUADRUPLE

**Masking Description:** active and placebo capsules identical visually.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** first dose level with 6 active and 2 placebo healthy participants

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** SAD cohort 1A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** second dose level with 6 active and 2 placebo healthy participants

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** SAD cohort 1B

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** SAD cohort 1C

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** fourth dose level with 6 active and 2 placebo healthy participants

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** SAD cohort 1D

**Type:** EXPERIMENTAL

#### Arm Group 5

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

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** MAD cohort 2A

**Type:** EXPERIMENTAL

#### Arm Group 6

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

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** MAD cohort 2B

**Type:** EXPERIMENTAL

#### Arm Group 7

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

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** MAD cohort 2C

**Type:** EXPERIMENTAL

#### Arm Group 8

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

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** MAD cohort 2D

**Type:** EXPERIMENTAL

#### Arm Group 9

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

**Intervention Names:**

- Drug: CC-42344

- Drug: Placebo

**Label:** MAD cohort 2E

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MAD cohort 2A

- MAD cohort 2B

- MAD cohort 2C

- MAD cohort 2D

- MAD cohort 2E

- SAD cohort 1A

- SAD cohort 1B

- SAD cohort 1C

- SAD cohort 1D

**Description:** CC-42344 capsules

**Name:** CC-42344

**Other Names:**

- Active

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- MAD cohort 2A

- MAD cohort 2B

- MAD cohort 2C

- MAD cohort 2D

- MAD cohort 2E

- SAD cohort 1A

- SAD cohort 1B

- SAD cohort 1C

- SAD cohort 1D

**Description:** Placebo capsules

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** number of participants with treatment-emergent adverse events

**Measure:** treatment emergent adverse events

**Time Frame:** Day 1 to 7 days after last dose

**Description:** number of participants with clinically significant laboratory abnormalities

**Measure:** laboratory abnormalities

**Time Frame:** Day 1 to 7 days after last dose

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

**Measure:** vital signs

**Time Frame:** Day 1 to 7 days after last dose

**Description:** number of participants with clinically significant changes from baseline in ECGs

**Measure:** ECG

**Time Frame:** Day 1 to 7 days after last dose

#### Secondary Outcomes

**Description:** measurement of maximum plasma concentration (Cmax)

**Measure:** maximum plasma concentration

**Time Frame:** Day 1 to 7 days after last dose

**Description:** measurement of time of maximum plasma concentration (Tmax)

**Measure:** time of maximum plasma concentration

**Time Frame:** Day 1 to 7 days after last dose

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

**Measure:** area under the plasma concentration-time curve

**Time Frame:** Day 1 to 7 days after last dose

**Description:** measurement of elimination rate constant

**Measure:** elimination rate constant

**Time Frame:** Day 1 to 7 days after last dose

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

**Measure:** terminal elimination half-life

**Time Frame:** Day 1 to 7 days after last dose

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nedlands

**Country:** Australia

**Facility:** Linear Clinical Research

**State:** Western Australia

**Zip:** 6009

#### Overall Officials

**Official 1:**

**Affiliation:** Linear Clinical Research

**Name:** Sam Salman, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009976

- Term: Orthomyxoviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: HIGH

- As Found: Influenza

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12902

- Name: Orthomyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007251

- Term: Influenza, Human

### Misc Info Module

- Version Holder: 2024-05-24
