Phase 1 Study of CC-90005 in Healthy Subjects and Subjects With Moderate to Severe Plaque-type Psoriasis

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Parapsoriasis, Healthy Volunteers

In brief

To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.

Key facts

Study ID

NCT02502188

Run by

Celgene

People needed

24

Starts

2015-07-17

Expected to finish

2015-11-02

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Part 1 (Healthy Subjects)
• Subjects must satisfy the following criteria to be enrolled in the study:
• Female or male subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is in good health as determined by a physical examination at screening.
• Female subjects of childbearing potential (FCBP) 1 must:
• Have two negative pregnancy tests as verified by the Investigator prior to the first dose of Investigational Product (IP). She must agree to ongoing pregnancy testing during the course of the study, and prior to discharge from the clinical site. This applies even if the FCBP subject practices true abstinence from heterosexual contact.
• Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption, during the study (including dose interruptions) and for at least 28 days after discontinuation of IP.
• The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
• Female subjects NOT of childbearing potential must:
• a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening)
• Male subjects must:
• a. Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions and for at least 28 days after discontinuation of IP, even if he has undergone a successful vasectomy.
• Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
• Subject has platelet count, absolute neutrophil count, and absolute lymphocyte count above the lower limit of normal at screening.
• Subject has liver function tests below the upper limit of normal at screening.
• For all other clinical laboratory safety test parameters, the subject has results within normal limits or acceptable to the Investigator.
• Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
• Subject has a normal or clinically-acceptable 12-lead ECG at screening. In addition:
• If male, subject has a QTcF value ≤ 430 msec at screening.
• If female, subject has a QTcF value ≤ 450 msec at screening.
• Part 2 (Subjects with Moderate to Severe Plaque-type Psoriasis)
• Subjects must satisfy the following criteria to be enrolled in the study:
• Female or male subject is ≥ 18 and ≤ 70 years of age at the time of signing the ICF.

You may not qualify if…

• Part 1 (Healthy Subjects)
• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal (GI), renal, hepatic, CV, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject is pregnant or breastfeeding.
• Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).
• Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days prior to the first dose administration.
• Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration.
• Subject has used CYP3A inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP3A (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
• Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
• Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
• Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
• Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen.
• Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
• Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
• Subject had systemic infection within 30 days prior to the first dose administration.
• Subject has a previous history of autoimmune disease.
• Subject is part of the clinical staff personnel or a family member of the clinical site staff.
• Part 2 (Subjects with Moderate to Severe Plaque-type Psoriasis)
• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant and relevant medical condition (including but not limited to neurological, GI, renal, hepatic, CV, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major uncontrolled disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject is pregnant or breastfeeding.

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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