CC-42344 Safety Study in Healthy Participants

Study Overview
=================
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.

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

Conditions
-----------------
Influenza A

Intervention / Treatment
-----------------
* Drug: CC-42344
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 4 cohorts for SAD, with food cohort; 5 cohorts for MAD; 6 active and 2 placebo per cohort; 6 additional active in food cohort
Masking: Quadruple


Arms and Interventions

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

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 |