Healthy Volunteers
Conditions
Keywords
Coronavirus, SARS-CoV-2
Brief summary
The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers. The main questions it aims to answer are: * Are there any side effects of the drug? * What is the amount of drug that reaches the bloodstream? Participants will be assigned by chance to take either CDI-988 or placebo by mouth and have physical exams, electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.
Detailed description
CDI-988 is a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 3-chymotrypsin-like (3CL) protease inhibitor for oral administration. This study is being conducted in 2 parts to examine the safety, tolerability, and PK of CDI-988 in healthy participants. Part 1 will entail escalating single doses in sequential cohorts and Part 2 will enroll escalating multiple-dose cohorts. Participants will be monitored for adverse events, vital signs, laboratory values, and electrocardiograms (ECGs).
Interventions
DRUGCDI-988
SARS-CoV-2 3CL protease inhibitor
DRUGPlacebo
matching placebo
Sponsors
Cocrystal Pharma, Inc.
Cocrystal Pharma Australia Pty Ltd.
Beyond Drug Development Pty Ltd.
Resolutum Global Pty Ltd.
Scientia Clinical Research Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part 1: 5 randomized single ascending dose cohorts of 8 participants and 1 open-label single ascending dose cohort of 6 participants. In Part 2, 6 multiple ascending dose cohorts, each with 8 participants
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or non-pregnant, non-lactating females * Body weight of at least 45 kg. * Body mass index ≥18.0 and ≤32.0 kg/m2 * Good state of mental and physical health * Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
Exclusion criteria
* Received an investigational drug within 30 days * Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days * Drug or alcohol abuse in the past 12 months * Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test results * Clinically significant abnormal ECG or vital signs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 17 days | number of participants with treatment-emergent adverse events |
| Laboratory Abnormalities | Up to 17 days | number of participants with clinically significant laboratory abnormalities |
| Vital Signs | Day 1 to 7 days after last dose | number of participants with clinically significant changes from baseline in vital signs |
| ECGs | Day 1 to 7 days after last dose | number of participants with clinically significant changes from baseline in ECGs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 SAD Maximum Plasma Concentration (Cmax) | predose, 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) | predose, 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 (AUC) From Time 0 to t (AUC0-t) of CDI-988 | pre dose, 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 (Lambda Z) | predose, 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) | predose, 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 2 MAD: Maximum Plasma Concentration (Cmax) of CDI-988 | Day 1, Day 5 and Day 10: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36 and 48h post-dose | Cmax was evaluated from the PK samples collected. |
| Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CDI-988 | Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h | Tmax was evaluated from the PK samples collected. |
| Part 2 MAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CDI-988 | Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h | AUC0-t was calculated from the PK samples collected |
| Part 2 MAD: Elimination Rate Constant (λz) of CDI-988 | Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h | λz was evaluated from the PK samples collected |
| Part 2 MAD: Terminal Elimination Half-life (t1/2) of CDI-988 | Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h | T1/2 was evaluated from the PK samples collected |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORChristopher Argent, MD
Scientia Clinical Research
Participant flow
Recruitment details
Part 1 single-ascending dose (SAD) included Cohorts 1A, 1B, 1C, 1D, 1E and 1F. Part 2, the multiple-ascending dose (MAD), included cohorts 1A, 2B, 2C, 2D, 2E, Cohort 2F.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 7.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 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 | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 2 / 6 | 2 / 6 | 3 / 6 | 2 / 6 | 4 / 10 | 0 / 6 | 1 / 6 | 0 / 6 | 1 / 4 | 3 / 6 | 3 / 6 | 3 / 6 | 2 / 6 | 3 / 6 | 5 / 6 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 |
Outcome results
None listed