Healthy
Conditions
Keywords
Phase 1, Healthy Volunteer, Safety, Healthy Volunteer Safety Study
Brief summary
The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.
Detailed description
Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.
Interventions
DRUGCC100
CC100 reconstituted in diluent
DRUGPlacebo
Diluent. Amount to match CC100 dose.
Sponsors
Chemigen, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal.
Exclusion criteria
* Have serious or unstable illnesses as determined by the investigator. * Have current or a history of asthma, or severe drug allergies or pollen allergy. * Have used medications (except for calcium supplements or externally applied eye drops or antibiotics) within 30 days prior to dosing or are expected to use other medications during the study. * Have had serious infectious disease affecting the brain within the preceding 5 years; or have known or existing evidence of serious infection. * Have laboratory test values that are considered clinically significant as determined by the investigator. * Have ECG abnormalities that are clinically significant. * Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing. * Have a history of chronic alcohol or drug abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsolicited Adverse Event Reports | Minimum of 24 hours after each dose. | Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| Half-Life (t1/2) | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CC100 (3 Single Doses) CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100 | 9 |
| CC100 (2 Single Doses) & Placebo(1 Dose) CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | CC100 (3 Single Doses) | CC100 (2 Single Doses) & Placebo(1 Dose) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 9 | 4 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Unsolicited Adverse Event Reports
Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.
Time frame: Minimum of 24 hours after each dose.
Population: All 18 subjects analyzed, per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC100 (3 Single Doses) | Unsolicited Adverse Event Reports | 3 Unsolicited Adverse Event Reports |
| CC100 (2 Single Doses) & Placebo(1 Dose) | Unsolicited Adverse Event Reports | 4 Unsolicited Adverse Event Reports |
Secondary
Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Population: 16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CC100 (3 Single Doses) | Half-Life (t1/2) | 18.5 hours | Standard Error 14.2 |
Secondary
Pharmacokinetics (PK)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Population: 16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CC100 (3 Single Doses) | Pharmacokinetics (PK) | 2.7 hours | Standard Error 2.3 |