Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis

Inclusion Criteria

• •Potential subjects must satisfy all of the following criteria to be enrolled into the study:
• •1. Subject ≥ 18 years of age.
• •2. Documented clinical diagnosis of a fibrotic lung disease supported by at least one of the following:
• •1. Usual interstitial pneumonia (UIP) pattern based on high-resolution computed tomography (HRCT).
• •OR
• •2. Nonspecific interstitial pneumonia (NSIP) pattern based on HRCT. OR
• •3. A documented fibrotic NSIP on surgical lung biopsy. OR
• •4. A documented UIP pattern on surgical lung biopsy. The underlying etiology of the fibrotic lung disease may be of any cause, including, but NOT LIMITED TO any of the following: Connective tissue disease associated interstitial lung disease, idiopathic pulmonary fibrosis (IPF), environmental or chemical-related pulmonary fibrosis, other forms of interstitial pulmonary fibrosis, Hermansky-Pudlak syndrome.
• •3. Must understand and voluntarily sign a written Informed Consent Form prior to any study-related procedures being performed.
• •4. 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.
• •5. Asparate Aminotransferase (AST) or serum glutamic-oxaloacetic transaminase within limits of normal.
• •6. Alanine Aminotransferase (ALT) or serum glutamic pyruvic transaminase within limits of normal.
• •7. Total bilirubin and International Normalized Ratio (INR) within limits of normal.
• •8. No clinically significant laboratory test results as determined by the Investigator.
• •9. Male subjects agree to use barrier contraception NOT made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) while on CC 90001 and for at least 28 days after the last dose of study medication. A FCBP is defined as a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or who has not been naturally postmenopausal for at least 24 consecutive months (ie, who has had menses at any time in the preceding 24 consecutive months).
• •10. All FCBPs must have a negative pregnancy test at Screening and Day 1. Any FCBP who engages in activity in which conception is possible must use two forms of contraception simultaneously while on CC-90001 and for at least 28 days after taking the last dose of CC-90001: one highly effective form (ie, hormonal, intrauterine device, tubal ligation, vasectomized partner) and one additional form (latex condom or any nonlatex condom NOT made of natural \[animal\] membrane \[eg, polyurethane\], diaphragm, sponge). If one highly effective form of contraception cannot be used, then two forms of barrier contraception must be used, ie, latex condom or any nonlatex condom NOT made out of natural (animal) membrane \[eg, polyurethane\] with either of the following: sponge with spermicide or diaphragm with spermicide.
• •11. Female subjects that are postmenopausal (defined as 24 months without menses before Screening, with an estradiol level of \< 30 pg/mL and FSH level of \> 40 IU/L at Screening).