CC-42344 Safety Study in Healthy Participants

Influenza A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202379
• Other study ID #: CC-42344-P1-001
• Status: Completed
• Phase: Phase 1
• Start date: February 11, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: May 2023
• Source: Cocrystal Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza A
• Influenza, Human

Intervention

Drug:
• CC-42344
CC-42344 capsules
• Placebo
Placebo capsules

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Nedlands	Western Australia

Sponsors (3)

Lead Sponsor	Collaborator
Cocrystal Pharma, Inc.	Cocrystal Pharma Australia Pty Ltd., Linear Clinical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment emergent adverse events	number of participants with treatment-emergent adverse events	Day 1 to 7 days after last dose
Primary	laboratory abnormalities	number of participants with clinically significant laboratory abnormalities	Day 1 to 7 days after last dose
Primary	vital signs	number of participants with clinically significant changes from baseline in vital signs	Day 1 to 7 days after last dose
Primary	ECG	number of participants with clinically significant changes from baseline in ECGs	Day 1 to 7 days after last dose
Secondary	maximum plasma concentration	measurement of maximum plasma concentration (Cmax)	Day 1 to 7 days after last dose
Secondary	time of maximum plasma concentration	measurement of time of maximum plasma concentration (Tmax)	Day 1 to 7 days after last dose
Secondary	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
Secondary	elimination rate constant	measurement of elimination rate constant	Day 1 to 7 days after last dose
Secondary	terminal elimination half-life	measurement of terminal elimination half-life (t1/2)	Day 1 to 7 days after last dose