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Completed

NCT Number: NCT05202379

CC-42344 Safety Study in Healthy Participants

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

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Key information

Conditions

Influenza A

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-42344

Drug

CC-42344 capsules

Other names: Active

Placebo

Drug

Placebo capsules

Primary outcomes

  1. Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

    Time frame: Up to 16 days

    AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.

  2. Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Up to 16 days

    Number of participants with clinically significant laboratory abnormalities was reported.

  3. Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs

    Time frame: Up to 16 days

    Number of participants with clinically significant changes from baseline in vital signs was reported

  4. Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)

    Time frame: Up to 16 days

    Number of participants with clinically significant changes from baseline in ECG was reported

  5. Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

    Time frame: Up to 21 days

    AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.

  6. Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Up to 21 days

    Number of participants with clinically significant laboratory abnormalities was reported

  7. Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs

    Time frame: Up to 21 days

    Number of participants with clinically significant changes from baseline in vital signs was reported

  8. Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)

    Time frame: Up to 14 days

    Number of participants with clinically significant changes from baseline in ECGs was reported.

Secondary outcomes

  1. Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344

    Time frame: Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    Cmax was evaluated from the PK samples collected.

  2. Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344

    Time frame: Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    Tmax was evaluated from the PK samples collected.

  3. Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344

    Time frame: Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    AUC0-t was evaluated from the PK samples collected.

  4. Part 1 SAD: Elimination Rate Constant (λz) of CC-42344

    Time frame: Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    λz was evaluated from the PK samples collected.

  5. Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344

    Time frame: Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    t1/2 was evaluated from the PK samples collected.

  6. Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344

    Time frame: Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    AUC0-inf was evaluated from the PK samples collected.

  7. Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed

    Time frame: Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    Cmax was evaluated from the PK samples collected.

  8. Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed

    Time frame: Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    Tmax was evaluated from the PK samples collected.

  9. Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed

    Time frame: Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    AUC0-t was evaluated from the PK samples collected.

  10. Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed

    Time frame: Day 1 and Day 9: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

    AUC0-inf was evaluated from the PK samples collected.

  11. Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344

    Time frame: Day 1: Pre-dose through 24 h post-dose, Day 5: Pre-dose through 96 h post-dose, and Day 14: Pre-dose through 96 h post-dose

    Cmax was evaluated from the PK samples collected.

  12. Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344

    Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, and 24 h post-dose Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4,

    Tmax was evaluated from the PK samples collected.

  13. Part 2 MAD: Elimination Rate Constant (λz) of CC-42344

    Time frame: Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose

    λz was evaluated from the PK samples collected.

  14. Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344

    Time frame: Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose

    T1/2 was evaluated from the PK samples collected.

Sponsors and collaborators

Lead sponsor

Cocrystal Pharma, Inc.

Industry

Collaborators

  • Cocrystal Pharma Australia Pty Ltd.
  • Linear Clinical Research

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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