CC-42344 Safety Study in Healthy Participants

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

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

Study Overview

• Status: Completed
• Conditions: Influenza A
• Intervention / Treatment: Drug: Placebo; Drug: CC-42344

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD cohort 1A; first dose level with 6 active and 2 placebo healthy participants	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: SAD cohort 1B; second dose level with 6 active and 2 placebo healthy participants	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: SAD cohort 1D; fourth dose level with 6 active and 2 placebo healthy participants	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: MAD cohort 2A; first dose level with 6 active and 2 placebo healthy participants dose x 14 days	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: MAD cohort 2B; second dose level with 6 active and 2 placebo healthy participants dose x 14 days	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: SAD cohort 1C; third dose level with 12 active and 2 placebo healthy participants; food-effect cohort	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: MAD cohort 2C; third dose level with 6 active and 2 placebo healthy participants dose x 14 days	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: MAD cohort 2D; forth dose level with 6 active and 2 placebo healthy participants dose x 5 days	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active
Experimental: MAD cohort 2E; forth dose level with 6 active and 2 placebo healthy participants dose x 5 days	Drug: Placebo; Placebo capsules; Drug: CC-42344; CC-42344 capsules; Other Names: Active

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.	Up to 16 days
Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities	Number of participants with clinically significant laboratory abnormalities was reported.	Up to 16 days
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	Number of participants with clinically significant changes from baseline in vital signs was reported	Up to 16 days
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)	Number of participants with clinically significant changes from baseline in ECG was reported	Up to 16 days
Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.	Up to 21 days
Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities	Number of participants with clinically significant laboratory abnormalities was reported	Up to 21 days
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	Number of participants with clinically significant changes from baseline in vital signs was reported	Up to 21 days
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)	Number of participants with clinically significant changes from baseline in ECGs was reported.	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344	Cmax was evaluated from the PK samples collected.	Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344	Tmax was evaluated from the PK samples collected.	Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344	AUC0-t was evaluated from the PK samples collected.	Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Elimination Rate Constant (λz) of CC-42344	λz was evaluated from the PK samples collected.	Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344	t1/2 was evaluated from the PK samples collected.	Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344	AUC0-inf was evaluated from the PK samples collected.	Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed	Cmax was evaluated from the PK samples collected.	Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed	Tmax was evaluated from the PK samples collected.	Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed	AUC0-t was evaluated from the PK samples collected.	Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed	AUC0-inf was evaluated from the PK samples collected.	Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose
Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344	Cmax was evaluated from the PK samples collected.	Day 1: Pre-dose through 24 h post-dose, Day 5: Pre-dose through 96 h post-dose, and Day 14: Pre-dose through 96 h post-dose
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344	Tmax was evaluated from the PK samples collected.	Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, and 24 h post-dose Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4,
Part 2 MAD: Elimination Rate Constant (λz) of CC-42344	λz was evaluated from the PK samples collected.	Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344	T1/2 was evaluated from the PK samples collected.	Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose

Collaborators and Investigators

• Sponsor: Cocrystal Pharma, Inc.
• Collaborators: Cocrystal Pharma Australia Pty Ltd.; Linear Clinical Research
• Investigators: Principal Investigator: Sam Salman, MD, Linear Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: CC-42344-P1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No