A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of CC-93538 in Healthy Japanese and Caucasian Adult Subjects

Celgene1 个研究点分布在 1 个国家目标入组 48 人2019年10月14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: 48
试验地点: 1
主要终点: Pharmacokinetics - CL/F
状态: 已完成
最后更新: 5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, safety, tolerability and immunogenicity of single SC doses of CC-93538 in healthy Japanese and Caucasian adult subjects.

A total of approximately 48 subjects, 24 Japanese and 24 Caucasians, will be enrolled. Japanese subjects will be enrolled first and randomized 1:1 to receive a single SC dose of either 180 mg or 360 mg CC-93538. Caucasian subjects will then be enrolled and matched to Japanese subjects (1:1) by weight (± 20%) and receive the same single SC dose of either 180 mg or 360 mg CC-93538.

注册库

clinicaltrials.gov

开始日期

2019年10月14日

结束日期

2020年1月30日

最后更新

5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. Japanese and Caucasian subjects will be matched by body weight (± 20%).
•Japanese subjects must have been born in Japan and not have lived outside of Japan \> 5 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
•Caucasian subjects must be of European or Latin American descent (ie, White).
•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). Acceptable methods of birth control in this study are the following:

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 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, if known (whichever was longer).
•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 used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, electronic cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to Day 1 and during the study.
•Subject has a positive urine drug test including cotinine, 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

研究组 & 干预措施

CC-93538 in Japanese subjects

Twenty-four Japanese subjects will be randomized into 1 of 2 dose levels in a 1:1 fashion so that 12 subjects will receive a 180 mg or 360 mg dose via SC injection.

干预措施: CC-93538

Administration of CC-93538 in Caucasian subjects

Twenty-four Caucasian subjects will be matched to Japanese subjects by weight (± 20%) and receive a 180 mg or 360 mg dose via SC injection

干预措施: CC-93538