NCT03971825终止1 期
A Phase 1, Randomized, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This is a phase 1, randomized, single-center, 3-part, study to assess the safety, tolerability, PK, and PD, of single and multiple doses of CC-92252 in healthy adult subjects and multiple doses of CC-92252 in adult subjects with psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Part 1, Part 2, and Part 3
- •Subject is ≥ 18 and ≤ 55 years (Part 1 and Part 2) and age is ≥ 18 and ≤ 60 years (Part 3) of age at the time of signing the ICF.
- •Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •Subject has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 (Part 1 and Part 2) and BMI ≥ 18 and ≤ 33 kg/m2 (Part 3), at screening.
- •Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator.
- •Applicable to Part 3 only
- •Subject has a clinical diagnosis of stable plaque-type PsO at least 6 months prior to screening, defined as:
- •BSA ≥ 5% (at both screening and baseline), and sPGA score ≥ 3 (at both screening and baseline)
- •Must have at least two plaques, at least 3 x 3 centimeters (cm) in diameter. One plaque will be used for punch biopsy and the other for Target Plaque Severity Score (TPSS) evaluation.
- •Must be in generally good health (except for PsO) as judged by the Investigator
- •No prior exposure to systemic treatments or biologics for the treatment of psoriasis
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Part 1, Part 2, and Part 3
- •Subject has any significant medical condition that would prevent the subject from participating in the study.
- •a. Part 3 only: This exclusion does not apply to plaque psoriasis
- •History or presence of cancer
- •Presence of pre-cancerous conditions
- •History or presence of a systemic infection or any potentially opportunistic infections
- •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
- •Part 1 and Part 2 only: Subject was 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)
- •Part 1 and Part 2 only: Subject has used any prescribed systemic or topical medication within 30 days prior to the first dose administration.
- •Part 1 and Part 2 only: Subject has used any non-prescribed systemic or topical medication within 14 days prior to the first dose administration. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to and documented by the Investigator and Sponsor's Medical Monitor.
- •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 a history of hepatitis B and/or hepatitis C, or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening Note: Subjects who received hepatitis B vaccination and who test positive for hepatitis B surface antibody and negative for both hepatitis B surface antigen and hepatitis B core antibody remain eligible for study participation
- •Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported)
- •Vaccination within 30 days prior to the first dose administration or subject has plans to receive a vaccination during the course of the study
- •Subject has received immunization with a live or live attenuated vaccine within 2 months prior to the first dose administration or is planning to receive immunization with a live or live attenuated vaccine for 2 months following the last dose administration
- •Subject has a positive QuantiFERON®-TB Gold (or equivalent) TB test at screening or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) TB tests at screening
- •Subject has a history of incompletely treated Mycobacterium tuberculosis (TB) infection
- •Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to first dose administration.
- •Prolonged sun exposure or use of tanning booths Applicable to Part 3 only
- •Presence of non-plaque psoriasis
- •Subject has psoriasis flare within 4 weeks before screening
- •Presence of dermatological diseases other than plaque psoriasis
- •Presence of Psoriatic Arthritis
- •Use of topical therapy for psoriasis within 14 days of first dosing (including but not limited to corticosteroids, retinoids, vitamin D analog, calcineurin inhibitors, salicylic acid) Exceptions: low potency topical corticosteroids will be allowed as background therapy for treatment of psoriatic lesions of the face, axillae and groin in accordance with the manufacturers' suggested usage; subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions; Eucerin® cream (the standard emollient for this study; or equivalent) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to each clinic visit.
- •Use of systemic therapy for psoriasis within 30 days of first dose administration
- •Use of phototherapy for psoriasis within 30 days of first dose administration
- •Use of systemic biologic treatment within 24 weeks of first dose administration
- •Exposure to an immunosuppressive or immunomodulatory drug within 30 days of first dose administration, or five half-lives of the drug (whichever is longer)
- •Exposure 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)
研究组 & 干预措施
Administration of CC-92252 and Placebo in Healthy Subjects
Experimental
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks.
干预措施: CC-92252 (Drug)
Administration of CC-92252 and Placebo in Healthy Subjects
Experimental
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks.
干预措施: Placebo (Other)
Administration of CC-92252 and Placebo in Psoriasis subjects
Experimental
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks.
干预措施: CC-92252 (Drug)
Administration of CC-92252 and Placebo in Psoriasis subjects
Experimental
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Adverse Events (AEs)
时间窗: From enrollment until at least 28 days after completion of study treatment
Number of participants with adverse event
次要结局
- Pharmacokinetics - t1/2z(UP to 16 weeks)
- Pharmacokinetics - CL/F(Up to 16 weeks)
- Anti-drug Antibody Immunogenicity Anti-drug antibody(Up to 16 weeks)
- Pharmacokinetics - CL(Up to 16 weeks)
- Pharmacokinetics - Cmax(Up to 16 weeks)
- Pharmacokinetics - AUC0-t(Up to 16 weeks)
- Pharmacokinetics - AUC0-∞(Up to 16 weeks)
- Pharmacokinetics - Tmax(Up to 16 weeks)
- Pharmacokinetics - Vz/F(Up to 16 weeks)
- Pharmacokinetics - Vz(Up to 16 weeks)
- Assessment of Pharmacodynamic biomarkers(UP to 24 weeks)
研究者
研究点 (1)
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