Clinical trial NCT05202379: CC-42344 Safety Study in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza A
Lead sponsor: Cocrystal Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cocrystal Pharma Australia Pty Ltd.
name: Linear Clinical Research
First posted: 2022-01-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: treatment emergent adverse events
timeFrame: Day 1 to 7 days after last dose
measure: laboratory abnormalities
timeFrame: Day 1 to 7 days after last dose
measure: vital signs
timeFrame: Day 1 to 7 days after last dose
measure: ECG
timeFrame: Day 1 to 7 days after last dose
Secondary outcomes:
measure: maximum plasma concentration
timeFrame: Day 1 to 7 days after last dose
measure: time of maximum plasma concentration
timeFrame: Day 1 to 7 days after last dose
measure: area under the plasma concentration-time curve
timeFrame: Day 1 to 7 days after last dose
measure: elimination rate constant
timeFrame: Day 1 to 7 days after last dose
measure: terminal elimination half-life
timeFrame: Day 1 to 7 days after last dose
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: Linear Clinical Research
name: Sam Salman, MD
role: PRINCIPAL_INVESTIGATOR
References: