Japanese Pharmacokinetic Bridging Study for CC-93538

NCT04096105 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-93538-CP-001U1111-1238-7252
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy subjects; CC-93538; Japanese PK bridging

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetics - AUC0-last

  Area under the concentration-time curve calculated from time zero to the last measured concentration

  from pre-dose to up to Day 70

• Pharmacokinetics - AUC0-∞

  Area under the concentration-time curve calculated from time zero to infinity

  from pre-dose to up to Day 70

• Pharmacokinetics - Cmax

  Maximum observed concentration of drug

  from pre-dose to up to Day 70

• Pharmacokinetics - tmax

  Time to Cmax

  from pre-dose to up to Day 70

• Pharmacokinetics - t½

  Terminal elimination half-life

  from pre-dose to up to Day 70

• Pharmacokinetics - CL/F

  Apparent clearance of drug from serum after extravascular administration

  from pre-dose to up to Day 70

• Pharmacokinetics - Vz/F

  Apparent volume of distribution during the terminal phase

  from pre-dose to up to Day 70

Secondary Outcomes (2)

• Adverse Events (AEs)

  From the time the informed consent form (ICF) is signed and until 70 days after the last dose of CC-93538

• Immunogenicity profile for CC-93538

  from pre-dose to up to Day 70

Study Arms (2)

CC-93538 in Japanese subjects

EXPERIMENTAL

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.

Drug: CC-93538

Administration of CC-93538 in Caucasian subjects

EXPERIMENTAL

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

Drug: CC-93538

Interventions

CC-93538 DRUG

a single dose CC-93538 SC

Administration of CC-93538 in Caucasian subjects; CC-93538 in Japanese subjects

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Combined hormonal (containing oestrogen and progestogen) contraception, which may be oral, intravaginal, or transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable or implantable
• Placement of an intrauterine device or intrauterine hormone-releasing system
• Bilateral tubal occlusion
• Vasectomised partner

You may not qualify if:

• 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 1.
• 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 -1.
• Subject has donated greater than 400 mL of blood within 60 days prior to Day 1.
• Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Subject has a history of clinically significant allergic reaction to any drug, biologic, food, or vaccine.
• Subject has a history of major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to any IgG-containing agent.
• Subject fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to dosing (Day 1) and throughout the study
• Subject has tattoos (\> 25% of their body) or other skin markings (eg, scars) that, in the opinion of the investigator, would prevent visualization of dermatologic changes due to study treatment

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Study Officials

• Jonathan Tran, Pharm.D

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 19, 2019
• Study Start: October 14, 2019
• Primary Completion: January 29, 2020
• Study Completion: January 30, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)