A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different Dose Concentrations of CC-93538 in Healthy Adult Subjects

Celgene1 个研究点分布在 1 个国家目标入组 52 人2020年6月22日

适应症Healthy Volunteers

干预措施CC-93538

概览

阶段: 1 期
干预措施: CC-93538
疾病 / 适应症: Healthy Volunteers
发起方: Celgene
入组人数: 52
试验地点: 1
主要终点: Pharmacokinetic - AUC0-∞
状态: 已完成
最后更新: 4年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is an open-label, randomized, parallel design study to evaluate the PK comparability, safety, tolerability and immunogenicity of a single SC dose of 360 mg CC 93538 using two different drug concentrations, 180 mg/mL and 150 mg/mL, in healthy adult subjects.

A total of approximately 52 subjects will be enrolled and randomized 1:1 to receive a single 360 mg SC dose of CC-93538 using either 180 mg/mL (1 injection of 2 mL) or 150 mg/mL (2 injections of 1.2 mL each) drug concentrations.

注册库

clinicaltrials.gov

开始日期

2020年6月22日

结束日期

2021年5月26日

最后更新

4年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Celgene

责任方

Sponsor

入排标准

入选标准

•Subjects must satisfy the following criteria to be enrolled in the study:
•Subject must be male or non-pregnant female, aged ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
•Subject must have a body weight of at least 40 kg; a BMI ≥ 18 and ≤ 30 kg/m2 at screening and Day -
•Subject must be in good health, as determined by the Investigator on the basis of medical history, clinical laboratory safety test results, vital signs, 12-lead ECG, and PE at Screening.
•Female subjects not of childbearing potential must:
•Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or
•Postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle stimulating hormone \[FSH\] level in the postmenopausal range according to the laboratory used at Screening); FSH to be performed at the discretion of the Investigator in consultation with the Medical Monitor.
•Females of child-bearing potential (FCBP) must agree to practice a highly effective method of contraception throughout the study and for 5 months after the last dose of investigational product (IP). FCBP is a female who 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
•Acceptable methods of birth control in this study are the following:
•Combined hormonal (containing oestrogen and progestogen) contraception, which may be oral, intravaginal, or transdermal

排除标准

•The presence of any of the following will exclude a subject from enrollment:
•Subject has any significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•Subject has any condition (acute or chronic) 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 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, ifkn own (whichever was longer).
•Subject has previously received CC-93538 treatment (formerly known as RPC4046 and ABT-308).
•Subject has a history of infection within 30 days of dosing on Day
•Subject has a history of drug or alcohol abuse (as defined by the investigator), or addiction within 6 months prior to Screening.
•Subject has a positive urine drug test, or positive alcohol urine or breath test at Screening or on Day -
•Subject has donated greater than 400 mL of blood within 60 days prior to Day