CC-42344 Safety Study in Healthy Participants

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2022

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 56 healthy men or women aged between 18-55 will 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. Part 2: will involve a multiple-ascending dose (MAD) where 24 participants (3 groups of 8) will be randomised to receive an oral dose of study drug or placebo given once a day for 14 days. The placebo will look the same as the study drug but will not contain any medicine.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: SAD cohort 1A
    • first dose level with 6 active and 2 placebo healthy participants
  • Experimental: SAD cohort 1B
    • second dose level with 6 active and 2 placebo healthy participants
  • Experimental: SAD cohort 1C
    • third dose level with 6 active and 2 placebo healthy participants; food-effect cohort
  • Experimental: SAD cohort 1D
    • fourth dose level with 6 active and 2 placebo healthy participants
  • Experimental: MAD cohort 2A
    • first dose level with 6 active and 2 placebo healthy participants dose x 14 days
  • Experimental: MAD cohort 2B
    • second dose level with 6 active and 2 placebo healthy participants dose x 14 days
  • Experimental: MAD cohort 3B
    • third dose level with 6 active and 2 placebo healthy participants dose x 14 days

Clinical Trial Outcome Measures

Primary Measures

  • treatment emergent adverse events
    • Time Frame: Day 1 to Day 21
    • number of participants with treatment-emergent adverse events
  • laboratory abnormalities
    • Time Frame: Day 1 to Day 21
    • number of participants with clinically significant laboratory abnormalities
  • vital signs
    • Time Frame: Day 1 to Day 21
    • number of participants with clinically significant changes from baseline in vital signs
  • ECG
    • Time Frame: Day 1 to Day 14
    • number of participants with clinically significant changes from baseline in ECGs

Secondary Measures

  • maximum plasma concentration
    • Time Frame: Day 1 to Day 14
    • measurement of maximum plasma concentration (Cmax)
  • time of maximum plasma concentration
    • Time Frame: Day 1 to Day 14
    • measurement of time of maximum plasma concentration (Tmax)
  • area under the plasma concentration-time curve
    • Time Frame: Day 1 to Day 14
    • measurement of area under the plasma concentration-time curve (AUC)
  • elimination rate constant
    • Time Frame: Day 1 to Day 11
    • measurement of elimination rate constant
  • terminal elimination half-life
    • Time Frame: Day 1 to Day 11
    • measurement of terminal elimination half-life (t1/2)

Participating in This Clinical Trial

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 a coronavirus disease 2019 (COVID-19) vaccine within 2 weeks 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cocrystal Pharma, Inc.
  • Collaborator
    • Cocrystal Pharma Australia Pty Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sam Salman, MD, Principal Investigator, Linear Clinical Research
  • Overall Contact(s)
    • Sam Lee, PhD, (425) 750-7208, slee@cocrystalpharma.com

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