CC-42344 Safety Study in Healthy Participants

Phase 1

Completed

• Conditions: Influenza A
• Interventions: Drug: CC-42344; Drug: Placebo

• Registration Number: NCT05202379
• Lead Sponsor: Cocrystal Pharma, Inc.

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.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-21
• Study Start: 2022-02-11
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MAD cohort 2D	Placebo	forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
MAD cohort 2E	CC-42344	forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
MAD cohort 2E	Placebo	forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
SAD cohort 1D	Placebo	fourth dose level with 6 active and 2 placebo healthy participants
MAD cohort 2A	Placebo	first dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2B	CC-42344	second dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2B	Placebo	second dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2A	CC-42344	first dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2C	CC-42344	third dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2C	Placebo	third dose level with 6 active and 2 placebo healthy participants dose x 14 days
SAD cohort 1A	CC-42344	first dose level with 6 active and 2 placebo healthy participants
SAD cohort 1A	Placebo	first dose level with 6 active and 2 placebo healthy participants
SAD cohort 1B	CC-42344	second dose level with 6 active and 2 placebo healthy participants
MAD cohort 2D	CC-42344	forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
SAD cohort 1B	Placebo	second dose level with 6 active and 2 placebo healthy participants
SAD cohort 1C	CC-42344	third dose level with 12 active and 2 placebo healthy participants; food-effect cohort
SAD cohort 1C	Placebo	third dose level with 12 active and 2 placebo healthy participants; food-effect cohort
SAD cohort 1D	CC-42344	fourth dose level with 6 active and 2 placebo healthy participants

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
maximum plasma concentration	Day 1 to 7 days after last dose	measurement of maximum plasma concentration (Cmax)
area under the plasma concentration-time curve	Day 1 to 7 days after last dose	measurement of area under the plasma concentration-time curve (AUC)
time of maximum plasma concentration	Day 1 to 7 days after last dose	measurement of time of maximum plasma concentration (Tmax)
terminal elimination half-life	Day 1 to 7 days after last dose	measurement of terminal elimination half-life (t1/2)
elimination rate constant	Day 1 to 7 days after last dose	measurement of elimination rate constant

Trial Locations

Locations (1)

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia