CompletedNCT05202379Updated Feb 19, 2026Results posted

CC-42344 Safety Study in Healthy Participants

A Phase 1 interventional study of CC-42344 and Placebo in Influenza A, sponsored by Cocrystal Pharma, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Cocrystal Pharma, Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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 studied

Influenza A

In context

Lead sponsor

Cocrystal Pharma, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 80 participants (actual)

Study arms

Experimental
SAD cohort 1A
first dose level with 6 active and 2 placebo healthy participants
Drug: CC-42344 · Drug: Placebo
Experimental
SAD cohort 1B
second dose level with 6 active and 2 placebo healthy participants
Drug: CC-42344 · Drug: Placebo
Experimental
SAD cohort 1C
third dose level with 12 active and 2 placebo healthy participants; food-effect cohort
Drug: CC-42344 · Drug: Placebo
Experimental
SAD cohort 1D
fourth dose level with 6 active and 2 placebo healthy participants
Drug: CC-42344 · Drug: Placebo
Experimental
MAD cohort 2A
first dose level with 6 active and 2 placebo healthy participants dose x 14 days
Drug: CC-42344 · Drug: Placebo
Experimental
MAD cohort 2B
second dose level with 6 active and 2 placebo healthy participants dose x 14 days
Drug: CC-42344 · Drug: Placebo
Experimental
MAD cohort 2C
third dose level with 6 active and 2 placebo healthy participants dose x 14 days
Drug: CC-42344 · Drug: Placebo
Experimental
MAD cohort 2D
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
Drug: CC-42344 · Drug: Placebo
Experimental
MAD cohort 2E
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
Drug: CC-42344 · Drug: Placebo

Interventions

DrugCC-42344
CC-42344 capsules
Also known as: Active
DrugPlacebo
Placebo capsules

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 14 days

Secondary outcomes

Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344
Cmax was evaluated from the PK samples collected.
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
Tmax was evaluated from the PK samples collected.
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
AUC0-t was evaluated from the PK samples collected.
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
λz was evaluated from the PK samples collected.
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
t1/2 was evaluated from the PK samples collected.
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
AUC0-inf was evaluated from the PK samples collected.
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
Cmax was evaluated from the PK samples collected.
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
Tmax was evaluated from the PK samples collected.
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
AUC0-t was evaluated from the PK samples collected.
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
AUC0-inf was evaluated from the PK samples collected.
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
Cmax was evaluated from the PK samples collected.
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
Tmax was evaluated from the PK samples collected.
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
λz was evaluated from the PK samples collected.
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
T1/2 was evaluated from the PK samples collected.
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

Posted Feb 19, 2026

Participant flow

Recruitment Details: 2-part study Part 1 single-ascending dose (SAD) included Cohorts 1A, 1B, 1C, and 1D. Part 2, the multiple-ascending dose (MAD), included cohorts 1A, 2B, 2C, 2D, and 2E.

Participant flow — Overall Study
Milestone	Cohort 1A - 100mg CC-42344	Cohort 1A - Placebo	Cohort 1B- 200mg CC-42344	Cohort 1B - Placebo	Cohort 1C - 400mg CC-42344	Cohort 1C - Placebo	Cohort 1C-2 - 400mg CC-42344	Cohort 1D - 800mg CC-42344	Cohort 1D - Placebo	Cohort 2A - 50mg CC-42344	Cohort 2A - Placebo	Cohort 2B - 100mg CC-42344	Cohort 2B - Placebo	Cohort 2C - 200mg CC-42344	Cohort 2C - Placebo	Cohort 2D - 400mg CC-42344 QD	Cohort 2D - Placebo	Cohort 2E - 400mg CC-42344 BID	Cohort 2E - Placebo
Started	6	2	6	2	6	2	6	6	2	6	2	6	2	6	2	7	2	7	2
Completed	6	2	6	2	6	2	6	6	2	6	2	6	2	6	2	6	2	6	2
Not completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0
Withdrew: Withdrawal by subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Withdrew: Randomized not treated	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0

Outcome measures

PrimaryPart 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.

Time frame:: Up to 16 days
Reported as:: Number · Participants

Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Participants	Part 1 SAD - 100mg CC-42344 - Fasted	Part 1 SAD 200mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fed	Part 1 SAD - 800mg CC-42344 Fasted	Part 1 SAD - Placebo Fasted	Part 1 SAD - Placebo - Fed
Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	3	3	6	4	2	4	1

PrimaryPart 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities

Number of participants with clinically significant laboratory abnormalities was reported.

Time frame:: Up to 16 days
Reported as:: Number · Participants

Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities
Participants	Part 1 SAD - 100mg CC-42344 - Fasted	Part 1 SAD 200mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fed	Part 1 SAD - 800mg CC-42344 Fasted	Part 1 SAD - Placebo Fasted	Part 1 SAD - Placebo - Fed
Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities	0	0	0	0	0	0	0

PrimaryPart 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

Time frame:: Up to 16 days
Reported as:: Number · Participants

Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Participants	Part 1 SAD - 100mg CC-42344 - Fasted	Part 1 SAD 200mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fed	Part 1 SAD - 800mg CC-42344 Fasted	Part 1 SAD - Placebo Fasted	Part 1 SAD - Placebo - Fed
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	0	0	0	0	0	0	0

PrimaryPart 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

Time frame:: Up to 16 days
Reported as:: Number · Participants

Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
Participants	Part 1 SAD - 100mg CC-42344 - Fasted	Part 1 SAD 200mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fed	Part 1 SAD - 800mg CC-42344 Fasted	Part 1 SAD - Placebo Fasted	Part 1 SAD - Placebo - Fed
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)	0	0	0	0	0	0	0

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

Cmax was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344
nanogram per milliliter (ng/mL)	Cohort 1A - 100mg	Cohort 1B - 200mg	Cohort 1C-2 - 400mg	Cohort 1D - 800mg
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344	304 ± 92.4	600 ± 92.0	749 ± 96.1	4752 ± 46.3

SecondaryPart 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344

Tmax was evaluated from the PK samples collected.

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
Reported as:: Median · Hours

Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
Hours	Cohort 1A - 100mg	Cohort 1B - 200mg	Cohort 1C-2 - 400mg	Cohort 1D - 800mg
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344	1.25 (0.5 to 3.00)	2.00 (0.5 to 3.50)	1.50 (0.75 to 3.50)	1.50 (0.75 to 1.50)

SecondaryPart 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.

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
Reported as:: Geometric mean · hour*nanogram per milliliter (hr*ng/mL)

Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344
hournanogram per milliliter (hrng/mL)	Cohort 1A - 100mg	Cohort 1B - 200mg	Cohort 1C-2 - 400mg	Cohort 1D - 800mg
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344	609 ± 41.5	1939 ± 48.9	3316 ± 61.2	11851 ± 62.6

SecondaryPart 1 SAD: Elimination Rate Constant (λz) of CC-42344

λz was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · 1/hour

Part 1 SAD: Elimination Rate Constant (λz) of CC-42344
1/hour	Cohort 1A - 100mg	Cohort 1B - 200mg	Cohort 1C-2 - 400mg	Cohort 1D - 800mg
Part 1 SAD: Elimination Rate Constant (λz) of CC-42344	0.0918 ± 68.9	0.0645 ± 74.5	0.0410 ± 31.7	0.0303 ± 65.2

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

t1/2 was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · Hour

Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344
Hour	Cohort 1A - 100mg	Cohort 1B - 200mg	Cohort 1C-2 - 400mg	Cohort 1D - 800mg
Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344	7.55 ± 68.9	10.7 ± 74.5	16.9 ± 31.7	22.8 ± 65.2

PrimaryPart 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Time frame:: Up to 21 days
Reported as:: Number · Participants

Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Participants	Part 2 MAD - 50mg CC-42344 -Fed	Part 2 MAD - 100mg CC-42344 -Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Pooled Placebo - Fed
Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	5	3	3	4	2	8

PrimaryPart 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities

Number of participants with clinically significant laboratory abnormalities was reported

Time frame:: Up to 21 days
Reported as:: Number · Participants

Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities
Participants	Part 2 MAD - 50mg CC-42344 -Fed	Part 2 MAD - 100mg CC-42344 -Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Pooled Placebo - Fed
Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities	0	0	0	0	0	0

PrimaryPart 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

Time frame:: Up to 21 days
Reported as:: Number · Participants

Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Participants	Part 2 MAD - 50mg CC-42344 -Fed	Part 2 MAD - 100mg CC-42344 -Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Pooled Placebo - Fed
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	0	0	0	0	0	0

PrimaryPart 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.

Time frame:: Up to 14 days
Reported as:: Number · Participants

Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
Participants	Part 2 MAD - 50mg CC-42344 -Fed	Part 2 MAD - 100mg CC-42344 -Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Pooled Placebo - Fed
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)	0	0	0	0	0	0

SecondaryPart 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.

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
Reported as:: Geometric mean · hr*ng/mL

Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344
hr*ng/mL	Cohort 1A - 100mg	Cohort 1B - 200mg	Cohort 1C-2 - 400mg	Cohort 1D - 800mg
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344	627 ± 37.6	2204 ± 50.4	4934 ± 60.7	12824 ± 67.0

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

Cmax was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed
nanogram per milliliter (ng/mL)	Cohort 1C-2 - 400mg Fasted	Cohort 1C-2 - 400mg Fed
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed	749 ± 96.1	610 ± 40.8

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

Tmax was evaluated from the PK samples collected.

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
Reported as:: Median · Hours

Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed
Hours	Cohort 1C-2 - 400mg Fasted	Cohort 1C-2 - 400mg Fed
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed	1.50 (0.75 to 3.50)	2.50 (1.50 to 4.00)

SecondaryPart 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.

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
Reported as:: Geometric mean · hour*nanogram per milliliter (hr*ng/mL)

Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed
hournanogram per milliliter (hrng/mL)	Cohort 1C-2 - 400mg Fasted	Cohort 1C-2 - 400mg Fed
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed	3316 ± 61.2	2851 ± 43.1

SecondaryPart 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.

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
Reported as:: Geometric mean · hr*ng/mL

Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed
hr*ng/mL	Cohort 1C-2 - 400mg Fasted	Cohort 1C-2 - 400mg Fed
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed	4934 ± 60.7	3621 ± 36.6

SecondaryPart 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344

Cmax was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344
nanogram per milliliter (ng/mL)	Cohort 2A - 50mg	Cohort 2B - 100mg	Cohort 2C - 200mg	Cohort 2D - 400mg QD	Cohort 2E - 400mg BID
Day 1	162 ± 78.9	130 ± 40.9	302 ± 77.9	867 ± 63.8	621 ± 51.2
Last dose (Day 5 or 14)	99.4 ± 45.6	127 ± 39.8	281 ± 82.3	1250 ± 81.6	1015 ± 64.5

SecondaryPart 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344

Tmax was evaluated from the PK samples collected.

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,
Reported as:: Median · Hours

Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
Hours	Cohort 2A - 50mg	Cohort 2B - 100mg	Cohort 2C - 200mg	Cohort 2D - 400mg QD	Cohort 2E - 400mg BID
Day 1	1.76 (0.75 to 6.00)	2.25 (2.00 to 2.50)	2.01 (1.00 to 2.50)	2.25 (0.75 to 4.00)	2.75 (1.50 to 4.00)
Last dose (Day 5 or 14)	2.50 (1.00 to 3.52)	2.25 (1.00 to 2.50)	1.75 (0.75 to 4.00)	1.75 (1.50 to 4.02)	3.02 (1.50 to 4.00)

SecondaryPart 2 MAD: Elimination Rate Constant (λz) of CC-42344

λz was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · 1/hr

Part 2 MAD: Elimination Rate Constant (λz) of CC-42344
1/hr	Cohort 2A - 50mg	Cohort 2B - 100mg	Cohort 2C - 200mg	Cohort 2D - 400mg QD	Cohort 2E - 400mg BID
Part 2 MAD: Elimination Rate Constant (λz) of CC-42344	0.2340 ± 43.1	0.0304 ± 0	0.0503 ± 0	0.0766 ± 78.4	0.0581 ± 14.0

SecondaryPart 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344

T1/2 was evaluated from the PK samples collected.

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
Reported as:: Geometric mean · Hours

Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344
Hours	Cohort 2A - 50mg	Cohort 2B - 100mg	Cohort 2C - 200mg	Cohort 2D - 400mg QD	Cohort 2E - 400mg BID
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344	2.96 ± 43.1	22.8 ± 0	13.8 ± 0	9.05 ± 78.4	11.9 ± 14.0

Adverse events

Collected over Up to 21 days. Non-serious events are listed at a 0% frequency threshold.

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

Most frequent other events

Showing 10 of 53

Most frequent other events
Event	Part 1 SAD - 100mg CC-42344 - Fasted	Part 1 SAD 200mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fasted	Part 1 SAD - 400mg CC-42344 - Fed	Part 1 SAD - 800mg CC-42344 Fasted	Part 1 SAD - Placebo Fasted	Part 1 SAD - Placebo - Fed	Part 2 MAD - 50mg CC-42344 -Fed	Part 2 MAD - 100mg CC-42344 -Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Placebo - Fed
Vascular access site dermatitisInjury, poisoning and procedural complications	1/6	0/6	0/12	0/12	0/6	0/8	1/2	1/6	0/6	0/6	0/7	0/6	0/10
HeadacheNervous system disorders	0/6	1/6	2/12	0/12	2/6	3/8	0/2	0/6	2/6	2/6	0/7	1/6	1/10
Vessel puncture site bruiseGeneral disorders	0/6	0/6	0/12	0/12	0/6	0/8	0/2	0/6	0/6	2/6	0/7	0/6	0/10
Vascular access site bruisingInjury, poisoning and procedural complications	0/6	0/6	1/12	0/12	0/6	0/8	0/2	0/6	0/6	1/6	1/7	1/6	3/10
Back painMusculoskeletal and connective tissue disorders	0/6	0/6	1/12	0/12	0/6	0/8	0/2	0/6	0/6	0/6	0/7	0/6	2/10
DizzinessNervous system disorders	0/6	1/6	0/12	0/12	0/6	0/8	0/2	0/6	0/6	0/6	0/7	0/6	0/10
PresyncopeNervous system disorders	0/6	0/6	1/12	0/12	0/6	0/8	0/2	0/6	0/6	1/6	1/7	0/6	0/10
DiarrhoeaGastrointestinal disorders	0/6	0/6	1/12	0/12	0/6	0/8	0/2	1/6	0/6	0/6	0/7	0/6	0/10
Gastroesophageal reflux diseaseGastrointestinal disorders	0/6	1/6	0/12	0/12	0/6	0/8	0/2	0/6	0/6	0/6	0/7	0/6	0/10
VomitingGastrointestinal disorders	1/6	0/6	0/12	0/12	0/6	0/8	0/2	0/6	0/6	0/6	0/7	0/6	0/10

Baseline characteristics

The safety population included all participants who received at least one dose of study treatment

Age, Continuous
Age, Continuous(Years)	Part 1 100mg CC-42344 - Fasted	Part 1 200mg CC-42344 - Fasted	Part 1 400mg CC-42344 Fasted / Fed	Part 1 800mg CC-42344 - Fasted	Part 1 SAD - Placebo	Part 2 MAD - 50mg CC-42344 - Fed	Part 2 MAD - 100mg CC-42344 - Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Placebo - Fed	Total
Mean	29.3 ± 8.4	28.3 ± 7.7	28.9 ± 8.7	38.4 ± 12.1	39.4 ± 12.1	26.8 ± 5.0	22 ± 4.0	26.7 ± 5.7	31 ± 12.2	25.9 ± 2.9	27.1 ± 6.1	29.5 ± 8.7

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1 100mg CC-42344 - Fasted	Part 1 200mg CC-42344 - Fasted	Part 1 400mg CC-42344 Fasted / Fed	Part 1 800mg CC-42344 - Fasted	Part 1 SAD - Placebo	Part 2 MAD - 50mg CC-42344 - Fed	Part 2 MAD - 100mg CC-42344 - Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Placebo - Fed	Total
Female	3	2	7	4	4	5	2	5	4	5	8	49
Male	3	4	5	2	4	1	4	1	3	2	2	31

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1 100mg CC-42344 - Fasted	Part 1 200mg CC-42344 - Fasted	Part 1 400mg CC-42344 Fasted / Fed	Part 1 800mg CC-42344 - Fasted	Part 1 SAD - Placebo	Part 2 MAD - 50mg CC-42344 - Fed	Part 2 MAD - 100mg CC-42344 - Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Placebo - Fed	Total
Hispanic or Latino	1	1	3	0	1	1	0	1	0	1	0	9
Not Hispanic or Latino	5	5	9	6	7	5	6	5	7	6	10	71
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part 1 100mg CC-42344 - Fasted	Part 1 200mg CC-42344 - Fasted	Part 1 400mg CC-42344 Fasted / Fed	Part 1 800mg CC-42344 - Fasted	Part 1 SAD - Placebo	Part 2 MAD - 50mg CC-42344 - Fed	Part 2 MAD - 100mg CC-42344 - Fed	Part 2 MAD - 200mg CC-42344 -Fed	Part 2 MAD - 400mg CC-42344 QD - Fed	Part 2 MAD - 400mg CC-42344 BID - Fed	Part 2 MAD - Placebo - Fed	Total
Race — Native Hawaiian or Other Pacific Islander	0	0	0	0	0	1	0	0	0	0	1	2
Race — White	4	4	9	6	5	2	5	4	6	4	6	55
Race — Black or African American	0	0	0	0	0	1	0	0	1	2	0	4
Race — Asian	1	2	1	0	1	2	1	1	0	0	2	11
Race — Multiple	1	0	2	0	2	0	0	1	0	0	1	7
Race — American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0
Race — Other	0	0	0	0	0	0	0	0	0	1	0	1

Study locations

1 site

Linear Clinical Research
Nedlands, Western Australia 6009, Australia

References and documents

Study documents

Protocol and statistical analysis plan · Dec 17, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05202379
Lead sponsor: Cocrystal Pharma, Inc.
Collaborators: Cocrystal Pharma Australia Pty Ltd., Linear Clinical Research
Responsible party: Sponsor
First posted: Jan 21, 2022
Start date: Feb 11, 2022
Primary completion: Mar 29, 2023
Completion: Mar 29, 2023
Results posted: Feb 19, 2026
Last update: Feb 19, 2026

Study contacts

Sam Salman, MD

principal investigator · Linear Clinical Research

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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CC-42344 Safety Study in Healthy Participants

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