Healthy VolunteersPhase 1NCT04373187
Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects
A Phase 1 study testing CC-93538 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-93538
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 26 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- CC-93538
- Keywords
- CC-93538, Healthy Subjects, PK comparability between two different dose concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-93538Drug
one injection of 2mL
CC-93538Drug
two injections of 1.2mL
| Study group | Role | What they receive |
|---|---|---|
| CC-93538, 180mg/mL | Experimental | 26 healthy subjects will receive one injection of 2mL, 180mg/mL CC-93538 Receives: Drug: CC-93538 |
| CC-93538, 150mg/mL | Experimental | 26 healthy subjects will receive 2 injections of 1.2mL, 150mg/mL CC-93538 Receives: Drug: CC-93538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic - AUC0-∞
Area under the concentration-time curve calculated from time zero to infinity
Measured: From Day 0 to Day 105
Pharmacokinetic - Cmax
Maximum observed concentration of drug
Measured: From Day 0 to Day 105
Secondary outcomes (6)
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From enrollment to Day 105
Pharmacokinetic - AUC0-last
Area under the concentration-time curve calculated from time zero to the last measured time point
Measured: From Day 0 to Day 105
Pharmacokinetic - tmax
Time to Cmax
Measured: From Day 0 to Day 105
Pharmacokinetic - t½
Terminal elimination half-life
Measured: From Day 0 to Day 105
Pharmacokinetic - CL/F
Apparent clearance of drug from serum after extravascular administration
Measured: From Day 0 to Day 105
Pharmacokinetic - Vz/F
Apparent volume of distribution during the terminal phase
Measured: From Day 0 to Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start22 Jun 2020
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373187
- Sponsor's protocol ID
- CC-93538-CP-002
- Other IDs
- U1111-1250-3915
- Status last verified
- Sep 2021
- First submitted
- 30 Apr 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04373187
- Acronym / sponsor ID
- CC-93538-CP-002
- Conditions
- Healthy Volunteers
- Keywords
- CC-93538, Healthy Subjects, PK comparability between two different dose concentrations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-93538, 180mg/mL | Experimental | Drug: CC-9353826 healthy subjects will receive one injection of 2mL, 180mg/mL CC-93538 |
| CC-93538, 150mg/mL | Experimental | Drug: CC-9353826 healthy subjects will receive 2 injections of 1.2mL, 150mg/mL CC-93538 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
- 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).
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-93538one injection of 2mL | Drug | CC-93538, 150mg/mL, CC-93538, 180mg/mL |
| CC-93538two injections of 1.2mL | Drug | CC-93538, 150mg/mL |
Primary outcome
Pharmacokinetic - AUC0-∞
Time frame: From Day 0 to Day 105
Area under the concentration-time curve calculated from time zero to infinity
Pharmacokinetic - Cmax
Time frame: From Day 0 to Day 105
Maximum observed concentration of drug
6 secondary outcomes
Adverse Events (AEs)
Time frame: From enrollment to Day 105
Pharmacokinetic - AUC0-last
Time frame: From Day 0 to Day 105
Pharmacokinetic - tmax
Time frame: From Day 0 to Day 105
Pharmacokinetic - t½
Time frame: From Day 0 to Day 105
Pharmacokinetic - CL/F
Time frame: From Day 0 to Day 105
Pharmacokinetic - Vz/F
Time frame: From Day 0 to Day 105
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-93538 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic - AUC0-∞ (time frame: From Day 0 to Day 105). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.