First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001

This is a 2-part study to be conducted at a single study center. Part 1 is a randomized,
double-blind, placebo-controlled study to evaluate the safety, tolerability, and
pharmacokinetics of CC-90001 following a single oral dose in healthy subjects. During the
course of Part 1, each subject will participate in a screening phase, a baseline phase, a
treatment phase and a follow up visit. There will be a total of 5 planned cohorts, each of
which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6
subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on
the randomization schedule. Administration of study drug at the next higher dose level will
not begin until the safety and tolerability of the preceding dose have been evaluated and
deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized,
double-blind, placebo-controlled study to evaluate the safety, tolerability, and
pharmacokinetics of CC-90001 following multiple oral doses in healthy subjects. Only doses
that are safe and well tolerated in Part 1 will be administered in Part 2. During the course
of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment
phase and a follow up visit. There will be a total of 5 planned cohorts, each of which will
consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects
will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the
randomization schedule. It is planned for study drug to be administered once daily for up to
14 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data
obtained from Part 1; however, the maximum dose administered in Part 2 will not exceed the
maximum tolerated dose in Part 1.

Inclusion Criteria:

- 1. Must understand and voluntarily sign a written informed consent prior to any
study-related procedures being performed.

2. Must be able to communicate with the investigator, understand and comply with the
requirements of the study, and agree to adhere to restrictions and examination
schedules.

3. Healthy male or female of any race between 18 to 50 years of age (inclusive) at
the time of signing the informed consent, and in good health as determined by a
physical examination at screening.

4. For males: Agree to use barrier contraception not made of natural (animal)
membrane [for example, latex or polyurethane condoms are acceptable]) when engaging
in sexual activity with a female of childbearing potential while on study medication,
and for at least 28 days after the last dose of study medication.

For females: Female subjects must have been surgically sterilized (hysterectomy or
bilateral oophorectomy; proper documentation required) at least 6 months before screening,
or be postmenopausal (defined as 24 months without menses before screening, with an
estradiol level of < 30 pg/mL and follicle-stimulating hormone level of > 40 IU/L at
screening).

5. Must have a body mass index between 18 and 33 kg/m2 (inclusive). 6. Platelet count,
absolute neutrophil count and absolute lymphocyte count must be above the lower limit of
normal at the screening visit.

7. Liver function tests must be below the upper limit of normal at screening. 8. All other
clinical laboratory tests must be within normal limits or acceptable to the investigator.

9. Subject must be afebrile, with supine systolic blood pressure: 90 to 140 mmHg, supine
diastolic blood pressure: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm at screening.

10. Must have a normal or clinically-acceptable 12-lead electrocardiogram at screening.
Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤
450 msec.

Exclusion Criteria:

- 1. History of any clinically significant and relevant neurological, gastrointestinal,
renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine,
hematological, allergic disease, drug allergies, or other major disorders.

2. Any condition which places the subject at unacceptable risk if he or she were to
participate in the study, or confounds the ability to interpret data from the study.

3. Exposed to an investigational drug (new chemical entity) within 30 days preceding
the first dose administration, or 5 half-lives of that investigational drug, if known
(whichever is longer).

4. Used any prescribed systemic or topical medication (including but not limited to
analgesics, anesthetics, etc) within 30 days of the first dose administration.

5. Used any non-prescribed systemic or topical medication (including vitamin/mineral
supplements, and herbal medicines) within 14 days of the first dose administration.

6. Used cytochrome P450 (CYP)3A inducers and inhibitors (including St. John's Wort)
within 30 days of the first dose administration.

7. Has any surgical or medical conditions possibly affecting drug absorption,
distribution, metabolism and excretion, for example, bariatric procedure.
Appendectomy and cholecystectomy are acceptable.

8. Donated blood or plasma within 8 weeks before the first dose administration to a
blood bank or blood donation center.

9. History of drug abuse (as defined by the current version of the Diagnostic and
Statistical Manual) within 2 years before dosing, or positive drug screening test
reflecting consumption of illicit drugs.

10. History of alcohol abuse (as defined by the current version of the Diagnostic and
Statistical Manual) within 2 years before dosing, or positive alcohol screen.

11. Known to have serum hepatitis or known to be a carrier of hepatitis B surface
antigen or hepatitis c antibody, or have a positive result to the test for human
immunodeficiency virus antibodies at screening.

12. Smoke more than 10 cigarettes per day, or the equivalent in other tobacco
products (self reported).

13. History of ulcerative colitis, Crohn's disease, diverticular disease, any
polyp(s) along the gastrointestinal tract, or colorectal cancer.

14. History of hemorrhoids, anal fissures, rectal ulcers, minor rectal bleeding (such
as red blood on toilet paper after wiping) within 5 years before the first dose
administration.

15. History of gastrointestinal bleeding or blood in stool within 5 years before the
first dose administration.

16. Any positive fecal occult blood test at screening and/or at any time prior to
first dosing.

17. Any history of constipation within 2 years before the first dose administration.

18. Subject does not routinely have a bowel movement, at minimum, every third day.

19. Any subject with a history of Irritable Bowel Syndrome or a history of frequent
abdominal cramping, frequent diarrhea, or frequent loose stools (with frequent
defined as once per week or greater).

20. Any female subject with menses (natural or artificial). 21. Any subject taking
hormonal contraception. 22. Subjects who are part of the clinical staff personnel or
family members of the clinical site staff.