Trial Outcomes & Findings for CC-42344 Safety Study in Healthy Participants (NCT NCT05202379)
NCT ID: NCT05202379
Last Updated: 2026-02-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Up to 16 days
Results posted on
2026-02-19
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 milestones
| Measure |
Cohort 1A - 100mg CC-42344
Participants received a single oral dose of 100 milligrams (mg) of CC42344 or a placebo on day 1.
|
Cohort 1A - Placebo
Participants received a single oral dose of placebo for CC42344 on day 1
|
Cohort 1B- 200mg CC-42344
Participants received a single oral dose of 200 mg of CC42344 on day 1.
|
Cohort 1B - Placebo
Participants received a single oral dose of placebo on day 1.
|
Cohort 1C - 400mg CC-42344
Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Cohort 1C - Placebo
Participants received a single oral dose of placebo on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Cohort 1C-2 - 400mg CC-42344
Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Cohort 1D - 800mg CC-42344
Participants received a single oral dose of 800 mg of CC42344 on day 1.
|
Cohort 1D - Placebo
Participants received a single oral dose of placebo on day 1.
|
Cohort 2A - 50mg CC-42344
Participants received 50 mg CC-42344 orally once daily (QD) from day 1 to day 14.
|
Cohort 2A - Placebo
Participants received placebo orally once daily (QD) from day 1 to day 14.
|
Cohort 2B - 100mg CC-42344
Participants received 100 mg CC-42344 QD from day 1 to day 14.
|
Cohort 2B - Placebo
Participants received placebo QD from day 1 to day 14.
|
Cohort 2C - 200mg CC-42344
Participants received 200 mg CC-42344 QD from day 1 to day 14.
|
Cohort 2C - Placebo
Participants received placebo QD from day 1 to day 14.
|
Cohort 2D - 400mg CC-42344 QD
Participants received 400 mg CC-42344 QD from day 1 to day 5.
|
Cohort 2D - Placebo
Participants received placebo QD from day 1 to day 5.
|
Cohort 2E - 400mg CC-42344 BID
Participants received 400 mg CC-42344 twice daily (BID) from day 1 to day 5.
|
Cohort 2E - Placebo
Participants received placebo twice daily (BID) from day 1 to day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
7
|
2
|
7
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1A - 100mg CC-42344
Participants received a single oral dose of 100 milligrams (mg) of CC42344 or a placebo on day 1.
|
Cohort 1A - Placebo
Participants received a single oral dose of placebo for CC42344 on day 1
|
Cohort 1B- 200mg CC-42344
Participants received a single oral dose of 200 mg of CC42344 on day 1.
|
Cohort 1B - Placebo
Participants received a single oral dose of placebo on day 1.
|
Cohort 1C - 400mg CC-42344
Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Cohort 1C - Placebo
Participants received a single oral dose of placebo on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Cohort 1C-2 - 400mg CC-42344
Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Cohort 1D - 800mg CC-42344
Participants received a single oral dose of 800 mg of CC42344 on day 1.
|
Cohort 1D - Placebo
Participants received a single oral dose of placebo on day 1.
|
Cohort 2A - 50mg CC-42344
Participants received 50 mg CC-42344 orally once daily (QD) from day 1 to day 14.
|
Cohort 2A - Placebo
Participants received placebo orally once daily (QD) from day 1 to day 14.
|
Cohort 2B - 100mg CC-42344
Participants received 100 mg CC-42344 QD from day 1 to day 14.
|
Cohort 2B - Placebo
Participants received placebo QD from day 1 to day 14.
|
Cohort 2C - 200mg CC-42344
Participants received 200 mg CC-42344 QD from day 1 to day 14.
|
Cohort 2C - Placebo
Participants received placebo QD from day 1 to day 14.
|
Cohort 2D - 400mg CC-42344 QD
Participants received 400 mg CC-42344 QD from day 1 to day 5.
|
Cohort 2D - Placebo
Participants received placebo QD from day 1 to day 5.
|
Cohort 2E - 400mg CC-42344 BID
Participants received 400 mg CC-42344 twice daily (BID) from day 1 to day 5.
|
Cohort 2E - Placebo
Participants received placebo twice daily (BID) from day 1 to day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomized not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The safety population included all participants who received at least one dose of study treatment
Baseline characteristics by cohort
| Measure |
Part 1 100mg CC-42344 - Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CC42344 on day 1.
|
Part 1 200mg CC-42344 - Fasted
n=6 Participants
Participants received a single oral dose of 200 mg of CC42344 on day 1.
|
Part 1 400mg CC-42344 Fasted / Fed
n=12 Participants
Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions.
|
Part 1 800mg CC-42344 - Fasted
n=6 Participants
Participants received a single oral dose of 800 mg of CC42344 on day 1.
|
Part 1 SAD - Placebo
n=8 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1 and under fed conditions on Day 9
|
Part 2 MAD - 50mg CC-42344 - Fed
n=6 Participants
Participants received 50 mg CC-42344 orally once daily (QD) from day 1 to day 14.
|
Part 2 MAD - 100mg CC-42344 - Fed
n=6 Participants
Participants received 100 mg CC-42344 QD from day 1 to day 14.
|
Part 2 MAD - 200mg CC-42344 -Fed
n=6 Participants
Participants received 200 mg CC-42344 QD from day 1 to day 14.
|
Part 2 MAD - 400mg CC-42344 QD - Fed
n=7 Participants
Participants received 400 mg CC-42344 QD from day 1 to day 5.
|
Part 2 MAD - 400mg CC-42344 BID - Fed
n=7 Participants
Participants received 400 mg CC-42344 BID from day 1 to day 5.
|
Part 2 MAD - Placebo - Fed
n=10 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 1 to day 5 or day 1 to day 14.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.3 Years
STANDARD_DEVIATION 8.4 • n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
28.3 Years
STANDARD_DEVIATION 7.7 • The safety population included all participants who received at least one dose of study treatment
|
28.9 Years
STANDARD_DEVIATION 8.7 • n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
38.4 Years
STANDARD_DEVIATION 12.1 • n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
39.4 Years
STANDARD_DEVIATION 12.1 • n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
26.8 Years
STANDARD_DEVIATION 5.0 • n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
22 Years
STANDARD_DEVIATION 4.0 • n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
26.7 Years
STANDARD_DEVIATION 5.7 • n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
31 Years
STANDARD_DEVIATION 12.2 • n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
25.9 Years
STANDARD_DEVIATION 2.9 • n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
27.1 Years
STANDARD_DEVIATION 6.1 • n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
29.5 Years
STANDARD_DEVIATION 8.7 • n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
The safety population included all participants who received at least one dose of study treatment
|
7 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
8 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
49 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
31 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
9 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
The safety population included all participants who received at least one dose of study treatment
|
9 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
7 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
7 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
10 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
71 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
The safety population included all participants who received at least one dose of study treatment
|
9 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
55 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
11 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · Multiple
|
1 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
7 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=4 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=250 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=3 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=5 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=204 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=6 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=72 Participants • The safety population included all participants who received at least one dose of study treatment
|
PRIMARY outcome
Timeframe: Up to 16 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
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.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=8 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
n=2 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 16 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
Number of participants with clinically significant laboratory abnormalities was reported.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=8 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
n=2 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 16 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
Number of participants with clinically significant changes from baseline in vital signs was reported
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=8 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
n=2 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 16 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
Number of participants with clinically significant changes from baseline in ECG was reported
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=12 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=8 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
n=2 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
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.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=7 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=10 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
|
4 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Number of participants with clinically significant laboratory abnormalities was reported
Number of participants with clinically significant laboratory abnormalities was reported
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=7 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=10 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
Number of participants with clinically significant changes from baseline in vital signs was reported
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=7 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=10 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo)
Number of participants with clinically significant changes from baseline in ECGs was reported.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=7 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
n=10 Participants
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
Cmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=5 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344
|
4752 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 46.3
|
—
|
304 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 92.4
|
600 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 92.0
|
749 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 96.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
Tmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=5 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
|
1.50 Hours
Interval 0.75 to 1.5
|
—
|
1.25 Hours
Interval 0.5 to 3.0
|
2.00 Hours
Interval 0.5 to 3.5
|
1.50 Hours
Interval 0.75 to 3.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
AUC0-t was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=5 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344
|
11851 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 62.6
|
—
|
609 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 41.5
|
1939 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 48.9
|
3316 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 61.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
λz was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=5 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=3 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=4 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=2 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Elimination Rate Constant (λz) of CC-42344
|
0.0303 1/hour
Geometric Coefficient of Variation 65.2
|
—
|
0.0918 1/hour
Geometric Coefficient of Variation 68.9
|
0.0645 1/hour
Geometric Coefficient of Variation 74.5
|
0.0410 1/hour
Geometric Coefficient of Variation 31.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
t1/2 was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=5 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=3 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=4 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=2 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344
|
22.8 Hour
Geometric Coefficient of Variation 65.2
|
—
|
7.55 Hour
Geometric Coefficient of Variation 68.9
|
10.7 Hour
Geometric Coefficient of Variation 74.5
|
16.9 Hour
Geometric Coefficient of Variation 31.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
AUC0-inf was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=5 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=3 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=4 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=2 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344
|
12824 hr*ng/mL
Geometric Coefficient of Variation 67.0
|
—
|
627 hr*ng/mL
Geometric Coefficient of Variation 37.6
|
2204 hr*ng/mL
Geometric Coefficient of Variation 50.4
|
4934 hr*ng/mL
Geometric Coefficient of Variation 60.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
Cmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed
|
—
|
—
|
749 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 96.1
|
610 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
Tmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed
|
—
|
—
|
1.50 Hours
Interval 0.75 to 3.5
|
2.50 Hours
Interval 1.5 to 4.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
AUC0-t was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed
|
—
|
—
|
3316 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 61.2
|
2851 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 43.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2
AUC0-inf was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=2 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=2 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed
|
—
|
—
|
4934 hr*ng/mL
Geometric Coefficient of Variation 60.7
|
3621 hr*ng/mL
Geometric Coefficient of Variation 36.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data.
Cmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344
Day 1
|
867 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63.8
|
621 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.2
|
162 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 78.9
|
130 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.9
|
302 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 77.9
|
—
|
—
|
|
Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344
Last dose (Day 5 or 14)
|
1250 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 81.6
|
1015 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64.5
|
99.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45.6
|
127 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.8
|
281 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 82.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 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,Population: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data.
Tmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=6 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=6 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=6 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
Day 1
|
2.25 Hours
Interval 0.75 to 4.0
|
2.75 Hours
Interval 1.5 to 4.0
|
1.76 Hours
Interval 0.75 to 6.0
|
2.25 Hours
Interval 2.0 to 2.5
|
2.01 Hours
Interval 1.0 to 2.5
|
—
|
—
|
|
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344
Last dose (Day 5 or 14)
|
1.75 Hours
Interval 1.5 to 4.02
|
3.02 Hours
Interval 1.5 to 4.0
|
2.50 Hours
Interval 1.0 to 3.52
|
2.25 Hours
Interval 1.0 to 2.5
|
1.75 Hours
Interval 0.75 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed.
λz was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=2 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=4 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=5 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=1 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=3 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Elimination Rate Constant (λz) of CC-42344
|
0.0766 1/hr
Geometric Coefficient of Variation 78.4
|
0.0581 1/hr
Geometric Coefficient of Variation 14.0
|
0.2340 1/hr
Geometric Coefficient of Variation 43.1
|
0.0304 1/hr
Geometric Coefficient of Variation 0
|
0.0503 1/hr
Geometric Coefficient of Variation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed.
T1/2 was evaluated from the PK samples collected.
Outcome measures
| Measure |
Cohort 2D - 400mg QD
n=2 Participants
Participants received an oral dose of 400 mg of CC-42344 once daily (QD) for 5 days.
|
Cohort 2E - 400mg BID
n=4 Participants
Participants received an oral dose of 400 mg of CC-42344 twice daily (BID) for 5 days.
|
Cohort 1A - 100mg
n=5 Participants
Participants received a single oral dose of 100 mg of CC-42344 on day 1
|
Cohort 1B - 200mg
n=1 Participants
Participants received a single oral dose of 200 mg of CC-42344 on day 1
|
Cohort 1C-2 - 400mg
n=3 Participants
Participants received an oral dose of 400 mg of CC-42344 under fasted conditions on day 1 and fed conditions on day 9
|
Part 1 SAD - Placebo Fasted
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1
|
Part 1 SAD - Placebo - Fed
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9
|
|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344
|
9.05 Hours
Geometric Coefficient of Variation 78.4
|
11.9 Hours
Geometric Coefficient of Variation 14.0
|
2.96 Hours
Geometric Coefficient of Variation 43.1
|
22.8 Hours
Geometric Coefficient of Variation 0
|
13.8 Hours
Geometric Coefficient of Variation 0
|
—
|
—
|
Adverse Events
Part 2 MAD - 400mg CC-42344 QD - Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 MAD - 400mg CC-42344 BID - Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 MAD - Placebo - Fed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 SAD - 100mg CC-42344 - Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 SAD 200mg CC-42344 - Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 SAD - 400mg CC-42344 - Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 SAD - 400mg CC-42344 - Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 SAD - 800mg CC-42344 Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD - Placebo Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 SAD - Placebo - Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 MAD - 50mg CC-42344 -Fed
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 MAD - 100mg CC-42344 -Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 MAD - 200mg CC-42344 -Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 2 MAD - 400mg CC-42344 QD - Fed
n=7 participants at risk
Participants received 400 mg CC-42344 QD from day 1 to day 5.
|
Part 2 MAD - 400mg CC-42344 BID - Fed
n=6 participants at risk
Participants received 400 mg CC-42344 twice daily (BID) from day 1 to day 5.
|
Part 2 MAD - Placebo - Fed
n=10 participants at risk
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions from day 1 to day 5 or day 1 to day 14
|
Part 1 SAD - 100mg CC-42344 - Fasted
n=6 participants at risk
Participants received a single oral dose of 100 milligrams (mg) of CC42344 on day 1.
|
Part 1 SAD 200mg CC-42344 - Fasted
n=6 participants at risk
Participants received a single oral dose of 200 mg of CC42344 on day 1.
|
Part 1 SAD - 400mg CC-42344 - Fasted
n=12 participants at risk
tParticipants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions.
|
Part 1 SAD - 400mg CC-42344 - Fed
n=12 participants at risk
Participants received a single oral dose of 400 mg of CC42344 on day 9, under fed conditions.
|
Part 1 SAD - 800mg CC-42344 Fasted
n=6 participants at risk
Participants received a single oral dose of 800 mg of CC42344 on day 1.
|
Part 1 SAD - Placebo Fasted
n=8 participants at risk
Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on Day 1
|
Part 1 SAD - Placebo - Fed
n=2 participants at risk
Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on Day 9
|
Part 2 MAD - 50mg CC-42344 -Fed
n=6 participants at risk
Participants received 50 mg CC-42344 once daily (QD) from day 1 to day 14.
|
Part 2 MAD - 100mg CC-42344 -Fed
n=6 participants at risk
Participants received 100 mg CC-42344 QD from day 1 to day 14.
|
Part 2 MAD - 200mg CC-42344 -Fed
n=6 participants at risk
Participants received 200 mg CC-42344 QD from day 1 to day 14.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
12.5%
1/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Nervous system disorders
Presyncope
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Change of Bowel habit
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
General disorders
fatigue
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
General disorders
Early satiety
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
General disorders
Catheter site pain
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
33.3%
2/6 • Up to 21 days
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
20.0%
2/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
12.5%
1/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Palate injury
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Eye disorders
Eye Irritation
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Eye disorders
Dry Eye
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
|
Infections and infestations
Paronychia
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Psychiatric disorders
Alcoholic hangover
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
12.5%
1/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
14.3%
1/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
10.0%
1/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
16.7%
2/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
33.3%
2/6 • Up to 21 days
Safety Population
|
37.5%
3/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
33.3%
2/6 • Up to 21 days
Safety Population
|
33.3%
2/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Vascular access site dermatitis
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
50.0%
1/2 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
14.3%
1/7 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
30.0%
3/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
|
Injury, poisoning and procedural complications
Vascular access site swelling
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
16.7%
1/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/7 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/10 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/12 • Up to 21 days
Safety Population
|
8.3%
1/12 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/8 • Up to 21 days
Safety Population
|
0.00%
0/2 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
0.00%
0/6 • Up to 21 days
Safety Population
|
Additional Information
David Huang, MD, PhD, Chief Medical Officer
Cocrystal Pharma
Phone: 936-577-5770
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction exists to protect Cocrystal's confidential and proprietary information, to ensure data integrity, and to coordinate the accurate and timely public disclosure of trial results.
- Publication restrictions are in place
Restriction type: OTHER