Healthy VolunteersPhase 1NCT04096105
Japanese Pharmacokinetic Bridging Study for CC-93538
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, 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. 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 30 Jan 2020
- 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. 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.
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- 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
- Sexual abstinence
- Male subjects must:
- Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a latex condom during sexual contact with FCBP while participating in the study until 5 months after the last dose of IP.
- Agree to refrain from donating sperm during the study until 5 months after the last dose of IP.
- Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- 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
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 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.
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- 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
- Subject has been diagnosed with or is being treated for a parasitic/helminthic infection or subject has systemic or diarrheal illness following travel or residence in endemic areas of parasitic/helminthic infections, history of clinical schistosomiasis, and history of travel to endemic areas within preceding 6 months.
- Subject has a history of tuberculosis, listeriosis, or untreated parasitic infections.
- 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 CC-93538 in Healthy Japanese and Caucasian Adult Subjects
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
- Being tested
- CC-93538
- Keywords
- Healthy subjects, CC-93538, Japanese PK bridging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-93538Drug
a single dose CC-93538 SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: CC-93538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - AUC0-last
Area under the concentration-time curve calculated from time zero to the last measured concentration
Measured: from pre-dose to up to Day 70
Pharmacokinetics - AUC0-∞
Area under the concentration-time curve calculated from time zero to infinity
Measured: from pre-dose to up to Day 70
Pharmacokinetics - Cmax
Maximum observed concentration of drug
Measured: from pre-dose to up to Day 70
Pharmacokinetics - tmax
Time to Cmax
Measured: from pre-dose to up to Day 70
Pharmacokinetics - t½
Terminal elimination half-life
Measured: from pre-dose to up to Day 70
Pharmacokinetics - CL/F
Apparent clearance of drug from serum after extravascular administration
Measured: from pre-dose to up to Day 70
Pharmacokinetics - Vz/F
Apparent volume of distribution during the terminal phase
Measured: from pre-dose to up to Day 70
Secondary outcomes (2)
Adverse Events (AEs)
Number participants with adverse event
Measured: 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
Positive or negative for the presence of antidrug antibodies against CC-93538 in blood
Measured: from pre-dose to up to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start14 Oct 2019
- Primary completion29 Jan 2020
- Study completion30 Jan 2020
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Tran, Pharm.D, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096105
- Sponsor's protocol ID
- CC-93538-CP-001
- Other IDs
- U1111-1238-7252
- Status last verified
- Aug 2020
- First submitted
- 4 Sep 2019
- Last updated
- 24 Aug 2020
- 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 24 Aug 2020. 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 CC-93538 in Healthy Japanese and Caucasian Adult Subjects
- ClinicalTrials.gov ID
- NCT04096105
- Acronym / sponsor ID
- CC-93538-CP-001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy subjects, CC-93538, Japanese PK bridging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 19 Sep 2019 (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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-93538 in Japanese subjects | Experimental | Drug: CC-93538Twenty-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. |
| Administration of CC-93538 in Caucasian subjects | Experimental | Drug: CC-93538Twenty-four Caucasian subjects will be matched to Japanese subjects by weight (± 20%) and receive a 180 mg or 360 mg dose via SC injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 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. 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.
Key exclusion criteria (21 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 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.
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-93538a single dose CC-93538 SC | Drug | Administration of CC-93538 in Caucasian subjects, CC-93538 in Japanese subjects |
Primary outcome
Pharmacokinetics - AUC0-last
Time frame: from pre-dose to up to Day 70
Area under the concentration-time curve calculated from time zero to the last measured concentration
Pharmacokinetics - AUC0-∞
Time frame: from pre-dose to up to Day 70
Area under the concentration-time curve calculated from time zero to infinity
Pharmacokinetics - Cmax
Time frame: from pre-dose to up to Day 70
Maximum observed concentration of drug
Pharmacokinetics - tmax
Time frame: from pre-dose to up to Day 70
Time to Cmax
Pharmacokinetics - t½
Time frame: from pre-dose to up to Day 70
Terminal elimination half-life
Pharmacokinetics - CL/F
Time frame: from pre-dose to up to Day 70
Apparent clearance of drug from serum after extravascular administration
Pharmacokinetics - Vz/F
Time frame: from pre-dose to up to Day 70
Apparent volume of distribution during the terminal phase
2 secondary outcomes
Adverse Events (AEs)
Time frame: 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
Time frame: from pre-dose to up to Day 70
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 24 Aug 2020.
- 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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Healthy Participants
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.
Jonathan Tran, Pharm.D study director
Celgene
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 21 inclusion and 21 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 24 Aug 2020. 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?
Pharmacokinetics - AUC0-last (time frame: from pre-dose to up to Day 70). The study lists 7 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 24 Aug 2020.