CC-42344 Safety Study in Healthy Participants

Cocrystal Pharma

Status and phase: Completed; Phase 1

Conditions: Influenza A

Treatments: Drug: CC-42344; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05202379

CC-42344-P1-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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80 participants in 9 patient groups

SAD cohort 1A

Experimental group

Description:

first dose level with 6 active and 2 placebo healthy participants

Treatment:

Drug: Placebo

Drug: CC-42344

SAD cohort 1B

Experimental group

Description:

second dose level with 6 active and 2 placebo healthy participants

Treatment:

Drug: Placebo

Drug: CC-42344

SAD cohort 1C

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: CC-42344

SAD cohort 1D

Experimental group

Description:

fourth dose level with 6 active and 2 placebo healthy participants

Treatment:

Drug: Placebo

Drug: CC-42344

MAD cohort 2A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: CC-42344

MAD cohort 2B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: CC-42344

MAD cohort 2C

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: CC-42344

MAD cohort 2D

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: CC-42344

MAD cohort 2E

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: CC-42344