Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects

NCT04373187 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-93538-CP-002U1111-1250-3915
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

CC-93538; Healthy Subjects; PK comparability between two different dose concentrations

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic - AUC0-∞

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

  From Day 0 to Day 105

• Pharmacokinetic - Cmax

  Maximum observed concentration of drug

  From Day 0 to Day 105

Secondary Outcomes (6)

• Adverse Events (AEs)

  From enrollment to Day 105

• Pharmacokinetic - AUC0-last

  From Day 0 to Day 105

• Pharmacokinetic - tmax

  From Day 0 to Day 105

• Pharmacokinetic - t½

  From Day 0 to Day 105

• Pharmacokinetic - CL/F

  From Day 0 to Day 105

Study Arms (2)

CC-93538, 180mg/mL

EXPERIMENTAL

26 healthy subjects will receive one injection of 2mL, 180mg/mL CC-93538

Drug: CC-93538

CC-93538, 150mg/mL

EXPERIMENTAL

26 healthy subjects will receive 2 injections of 1.2mL, 150mg/mL CC-93538

Drug: CC-93538

Interventions

CC-93538 DRUG

one injection of 2mL

CC-93538, 150mg/mL; CC-93538, 180mg/mL

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 and Day -1.
• 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
• 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
• Sexual abstinence

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 (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 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 a positive urine drug test, 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)

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  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: April 30, 2020
• First Posted: May 4, 2020
• Study Start: June 22, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

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)