Influenza A
Conditions
Brief summary
CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.
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.
Interventions
DRUGCC-42344
CC-42344 capsules
DRUGPlacebo
Placebo capsules
Sponsors
Cocrystal Pharma, Inc.
Cocrystal Pharma Australia Pty Ltd.
Linear Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
active and placebo capsules identical visually.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | 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 | 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 | 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) | 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) | 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 | 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 | 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) | Up to 14 days | Number of participants with clinically significant changes from baseline in ECGs was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 | 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. |
| Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 | 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. |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 | 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. |
| Part 1 SAD: Elimination Rate Constant (λz) of CC-42344 | 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. |
| Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344 | 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. |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 | 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. |
| Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed | 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. |
| Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed | 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. |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed | 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. |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed | 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. |
| Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344 | 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. |
| Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 | 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. |
| Part 2 MAD: Elimination Rate Constant (λz) of CC-42344 | 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. |
| Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344 | 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. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORSam Salman, MD
Linear Clinical Research
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.3 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 11 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants |
| Race/Ethnicity, Customized Race Multiple | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 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 |
| other Total, other adverse events | 3 / 6 | 3 / 6 | 6 / 12 | 4 / 12 | 2 / 6 | 4 / 8 | 1 / 2 | 5 / 6 | 3 / 6 | 3 / 6 | 4 / 7 | 2 / 6 | 8 / 10 |
| serious Total, serious adverse events | 0 / 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 |
Outcome results
None listed