Phase 1 N=80 Randomized Quadruple-blind Other

CC-42344 Safety Study in Healthy Participants

Influenza A

Bottom Line

View on ClinicalTrials.gov: NCT05202379 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) — 3; 3; 6; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CC-42344 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Cocrystal Pharma, Inc.
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	3; 3; 6; 4; 2; 4	—
PRIMARY Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)	0; 0; 0; 0; 0; 0	—
PRIMARY Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)	5; 3; 3; 4; 2; 8	—
PRIMARY Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities	0; 0; 0; 0; 0; 0	—
PRIMARY Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	0; 0; 0; 0; 0; 0	—
PRIMARY Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)	0; 0; 0; 0; 0; 0	—
SECONDARY Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344	304; 600; 749; 4752	—
SECONDARY Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344	1.25; 2.00; 1.50; 1.50	—
SECONDARY Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344	609; 1939; 3316; 11851	—
SECONDARY Part 1 SAD: Elimination Rate Constant (λz) of CC-42344	0.0918; 0.0645; 0.0410; 0.0303	—
SECONDARY Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344	7.55; 10.7; 16.9; 22.8	—
SECONDARY Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344	627; 2204; 4934; 12824	—
SECONDARY Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed	749; 610	—
SECONDARY Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed	1.50; 2.50	—
SECONDARY Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed	3316; 2851	—
SECONDARY Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed	4934; 3621	—
SECONDARY Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344	162; 130; 302; 867; 621; 99.4	—
SECONDARY Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344	1.76; 2.25; 2.01; 2.25; 2.75; 2.50	—
SECONDARY Part 2 MAD: Elimination Rate Constant (λz) of CC-42344	0.2340; 0.0304; 0.0503; 0.0766; 0.0581	—
SECONDARY Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344	2.96; 22.8; 13.8; 9.05; 11.9	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05202379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.