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

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participants needed

52
sponsor

Celgene

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Updated on 19 February 2024

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cancer

hysterectomy

oophorectomy

progestin

follicle stimulating hormone

hormonal contraception

12 lead ECG

tubal occlusion

12 lead electrocardiogram

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.

Details

Condition	Healthy Volunteers
Age	18years - 55years
Treatment	CC-93538
Clinical Study Identifier	NCT04373187
Sponsor	Celgene
Last Modified on	19 February 2024

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Inclusion Criteria
	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 5\. Subjects must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements. Must be able to communicate with the Investigator and to understand and adhere to the study visit schedule and other protocol requirements
Exclusion Criteria
	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
	Subject has an active parasitic/helminthic infection or suspected parasitic helminthic infection. Subjects with suspected infections may participate if clinical and laboratory
	Subject has been diagnosed with or is being treated for a clinical schistosomiasis
	Subject has a history of tuberculosis, or listeriosis
	Subject has a history of hereditary fructose intolerance
	Subject is, for any reason, deemed by the Investigator to be inappropriate for this study
	Subject has received any drug by injection within 30 days of Day 1
	Subject has poor peripheral venous access

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