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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum plasma concentration	measurement of maximum plasma concentration (Cmax)	Day 1 to 7 days after last dose
time of maximum plasma concentration	measurement of time of maximum plasma concentration (Tmax)	Day 1 to 7 days after last dose
area under the plasma concentration-time curve	measurement of area under the plasma concentration-time curve (AUC)	Day 1 to 7 days after last dose
elimination rate constant	measurement of elimination rate constant	Day 1 to 7 days after last dose
terminal elimination half-life	measurement of terminal elimination half-life (t1/2)	Day 1 to 7 days after last 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): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

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
• 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