Influenza APhase 1NCT05202379

CC-42344 Safety Study in Healthy Participants

A Phase 1 study testing CC-42344 in people with Influenza A, run by Cocrystal Pharma, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Influenza A
What is being tested?: CC-42344
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteAustralia
Study dates: 11 Feb 2022to 29 Mar 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Australia1 site

Linear Clinical Research
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

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

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

Read the 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.

Conditions: Influenza A
Being tested: CC-42344, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CC-42344Drug
Also called Active
CC-42344 capsules
PlaceboDrug
Placebo capsules

Study groups in NCT05202379
Study group	Role	What they receive
SAD cohort 1A	Experimental	first dose level with 6 active and 2 placebo healthy participants Receives: Drug: CC-42344; Drug: Placebo
SAD cohort 1B	Experimental	second dose level with 6 active and 2 placebo healthy participants Receives: Drug: CC-42344; Drug: Placebo
SAD cohort 1C	Experimental	third dose level with 12 active and 2 placebo healthy participants; food-effect cohort Receives: Drug: CC-42344; Drug: Placebo
SAD cohort 1D	Experimental	fourth dose level with 6 active and 2 placebo healthy participants Receives: Drug: CC-42344; Drug: Placebo
MAD cohort 2A	Experimental	first dose level with 6 active and 2 placebo healthy participants dose x 14 days Receives: Drug: CC-42344; Drug: Placebo
MAD cohort 2B	Experimental	second dose level with 6 active and 2 placebo healthy participants dose x 14 days Receives: Drug: CC-42344; Drug: Placebo
MAD cohort 2C	Experimental	third dose level with 6 active and 2 placebo healthy participants dose x 14 days Receives: Drug: CC-42344; Drug: Placebo
MAD cohort 2D	Experimental	forth dose level with 6 active and 2 placebo healthy participants dose x 5 days Receives: Drug: CC-42344; Drug: Placebo
MAD cohort 2E	Experimental	forth dose level with 6 active and 2 placebo healthy participants dose x 5 days Receives: Drug: CC-42344; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
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.
Measured: Up to 16 days
Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities was reported.
Measured: Up to 16 days
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Number of participants with clinically significant changes from baseline in vital signs was reported
Measured: Up to 16 days
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
Number of participants with clinically significant changes from baseline in ECG was reported
Measured: Up to 16 days
Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
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.
Measured: Up to 21 days
Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities was reported
Measured: Up to 21 days
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Number of participants with clinically significant changes from baseline in vital signs was reported
Measured: Up to 21 days
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
Number of participants with clinically significant changes from baseline in ECGs was reported.
Measured: Up to 14 days

Secondary outcomes (14)

Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344
Cmax was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
Tmax was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344
AUC0-t was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Elimination Rate Constant (λz) of CC-42344
λz was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344
t1/2 was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344
AUC0-inf was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed
Cmax was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed
Tmax was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed
AUC0-t was evaluated from the PK samples collected.
Measured: 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
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed
AUC0-inf was evaluated from the PK samples collected.
Measured: 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
Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344
Cmax was evaluated from the PK samples collected.
Measured: 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
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
Tmax was evaluated from the PK samples collected.
Measured: 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,
Part 2 MAD: Elimination Rate Constant (λz) of CC-42344
λz was evaluated from the PK samples collected.
Measured: 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
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344
T1/2 was evaluated from the PK samples collected.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 202229 Mar 2023

First posted21 Jan 2022
Study start11 Feb 2022
Primary completion29 Mar 2023
Study completion29 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Influenza AStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
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 blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05202379
Sponsor's protocol ID: CC-42344-P1-001
Status last verified: Jan 2026
First submitted: 10 Jan 2022
Last updated: 19 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05202379
Acronym / sponsor ID: CC-42344-P1-001
Conditions: Influenza A
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Cocrystal Pharma, Inc.Industry (pharma, biotech, devices)
Collaborators: Cocrystal Pharma Australia Pty Ltd., Linear Clinical Research
Study start: 11 Feb 2022 (actual)
Primary completion: 29 Mar 2023 (actual)
Study completion: 29 Mar 2023 (actual)
First posted: 21 Jan 2022 (actual)
Results: Posted 19 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9
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

Arm	Type	Receives
SAD cohort 1A	Experimental	Drug: CC-42344, Drug: Placebofirst dose level with 6 active and 2 placebo healthy participants
SAD cohort 1B	Experimental	Drug: CC-42344, Drug: Placebosecond dose level with 6 active and 2 placebo healthy participants
SAD cohort 1C	Experimental	Drug: CC-42344, Drug: Placebothird dose level with 12 active and 2 placebo healthy participants; food-effect cohort
SAD cohort 1D	Experimental	Drug: CC-42344, Drug: Placebofourth dose level with 6 active and 2 placebo healthy participants
MAD cohort 2A	Experimental	Drug: CC-42344, Drug: Placebofirst dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2B	Experimental	Drug: CC-42344, Drug: Placebosecond dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2C	Experimental	Drug: CC-42344, Drug: Placebothird dose level with 6 active and 2 placebo healthy participants dose x 14 days
MAD cohort 2D	Experimental	Drug: CC-42344, Drug: Placeboforth dose level with 6 active and 2 placebo healthy participants dose x 5 days
MAD cohort 2E	Experimental	Drug: CC-42344, Drug: Placeboforth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CC-42344Also: ActiveCC-42344 capsules	Drug	MAD cohort 2A, MAD cohort 2B, MAD cohort 2C, MAD cohort 2D, MAD cohort 2E, SAD cohort 1A, SAD cohort 1B, SAD cohort 1C, SAD cohort 1D
PlaceboPlacebo capsules	Drug	MAD cohort 2A, MAD cohort 2B, MAD cohort 2C, MAD cohort 2D, MAD cohort 2E, SAD cohort 1A, SAD cohort 1B, SAD cohort 1C, SAD cohort 1D

Primary outcome

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.
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.
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
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
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.
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
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
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.

14 secondary outcomes

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
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
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
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
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
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
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
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
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
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
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
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,
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
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

Results and safety

Results posted to the registry on 19 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1A - 100mg CC-42344	6	6
Cohort 1A - Placebo	2	2
Cohort 1B- 200mg CC-42344	6	6
Cohort 1B - Placebo	2	2
Cohort 1C - 400mg CC-42344	6	6
Cohort 1C - Placebo	2	2
Cohort 1C-2 - 400mg CC-42344	6	6
Cohort 1D - 800mg CC-42344	6	6
Cohort 1D - Placebo	2	2
Cohort 2A - 50mg CC-42344	6	6
Cohort 2A - Placebo	2	2
Cohort 2B - 100mg CC-42344	6	6
Cohort 2B - Placebo	2	2
Cohort 2C - 200mg CC-42344	6	6
Cohort 2C - Placebo	2	2
Cohort 2D - 400mg CC-42344 QD	7	6
Cohort 2D - Placebo	2	2
Cohort 2E - 400mg CC-42344 BID	7	6
Cohort 2E - Placebo	2	2

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

Time frame: Up to 16 days. Number. Unit: Participants

Measure	Part 1 SAD - 100mg CC-42344 - Fasted n = 6	Part 1 SAD 200mg CC-42344 - Fasted n = 6	Part 1 SAD - 400mg CC-42344 - Fasted n = 12	Part 1 SAD - 400mg CC-42344 - Fed n = 12	Part 1 SAD - 800mg CC-42344 Fasted n = 6	Part 1 SAD - Placebo Fasted n = 8	Part 1 SAD - Placebo - Fed n = 2
Value	3	3	6	4	2	4	1

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)

Primary outcome: Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities

Time frame: Up to 16 days. Number. Unit: Participants

Measure	Part 1 SAD - 100mg CC-42344 - Fasted n = 6	Part 1 SAD 200mg CC-42344 - Fasted n = 6	Part 1 SAD - 400mg CC-42344 - Fasted n = 12	Part 1 SAD - 400mg CC-42344 - Fed n = 12	Part 1 SAD - 800mg CC-42344 Fasted n = 6	Part 1 SAD - Placebo Fasted n = 8	Part 1 SAD - Placebo - Fed n = 2
Value	0	0	0	0	0	0	0

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)

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

Time frame: Up to 16 days. Number. Unit: Participants

Measure	Part 1 SAD - 100mg CC-42344 - Fasted n = 6	Part 1 SAD 200mg CC-42344 - Fasted n = 6	Part 1 SAD - 400mg CC-42344 - Fasted n = 12	Part 1 SAD - 400mg CC-42344 - Fed n = 12	Part 1 SAD - 800mg CC-42344 Fasted n = 6	Part 1 SAD - Placebo Fasted n = 8	Part 1 SAD - Placebo - Fed n = 2
Value	0	0	0	0	0	0	0

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)

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

Time frame: Up to 16 days. Number. Unit: Participants

Measure	Part 1 SAD - 100mg CC-42344 - Fasted n = 6	Part 1 SAD 200mg CC-42344 - Fasted n = 6	Part 1 SAD - 400mg CC-42344 - Fasted n = 12	Part 1 SAD - 400mg CC-42344 - Fed n = 12	Part 1 SAD - 800mg CC-42344 Fasted n = 6	Part 1 SAD - Placebo Fasted n = 8	Part 1 SAD - Placebo - Fed n = 2
Value	0	0	0	0	0	0	0

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 21 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 SAD - 100mg CC-42344 - Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1 SAD 200mg CC-42344 - Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1 SAD - 400mg CC-42344 - Fasted	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Part 1 SAD - 400mg CC-42344 - Fed	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part 1 SAD - 800mg CC-42344 Fasted	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1 SAD - Placebo Fasted	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Part 1 SAD - Placebo - Fed	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Part 2 MAD - 50mg CC-42344 -Fed	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part 2 MAD - 100mg CC-42344 -Fed	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 MAD - 200mg CC-42344 -Fed	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 MAD - 400mg CC-42344 QD - Fed	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Part 2 MAD - 400mg CC-42344 BID - Fed	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 2 MAD - Placebo - Fed	0 of 10 (0%)	8 of 10 (80%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Healthy Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sam Salman, MD principal investigator

Linear Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-42344 in people with Influenza A, run by Cocrystal Pharma, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) (time frame: Up to 16 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05202379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.