Healthy VolunteersPhase 1NCT02934269
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
A Phase 1 study testing CC-90006 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy 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-90006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 15 Aug 2017
- 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
- Healthy male and/or female subjects between the ages of 18 and 55 years, and a body mass index (BMI) of ≥ 18 and ≤ 33 kg/m2 with body weight ≥ 50 and ≤ 90 kg at screening.
- Females must have been surgically sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening).
Who cannot join
- Exposure/treatment to an investigational (new chemical entity) or marketed drug or biologic within 30 days preceding the first dose administration, or five half-lives of that investigational drug or biologic, if known (whichever is longer).
- Donation blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.
- History of alcohol or drug abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol or drug screen.
- Vaccination within 30 days prior to the first dose administration or has plans to receive a vaccination during the course of the study (including the follow phone call on Day 105).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy subjects.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending doses of CC-90006 in healthy subjects.
This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40 subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8 subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2 subjects).
Eligible subjects will check into the clinic site on the day before dosing (Day -1) and receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2), 22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be performed and blood samples will be collected for determination of levels of CC-90006 in the blood.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, CC-90006
- Keywords
- Healthy subjects, Safety, CC-90006, Phase 1, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
CC-90006Drug
| Study group | Role | What they receive |
|---|---|---|
| CC-90006; Dose Level 1 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen Receives: Drug: CC-90006 |
| CC-90006; Dose Level 2 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen Receives: Drug: CC-90006 |
| CC-90006; Dose Level 3 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen Receives: Drug: CC-90006 |
| CC-90006; Dose Level 4 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen Receives: Drug: CC-90006 |
| CC-90006; Dose Level 5 | Experimental | CC-90006 will be administered by subcutaneous injection in the abdomen Receives: Drug: CC-90006 |
| Placebo | Experimental | Placebo will be administered by subcutaneous injection in the abdomen Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to day 105
Secondary outcomes (8)
Pharmacokinetics- Cmax
Observed maximum serum concentration
Measured: Up to day 71
Pharmacokinetics- Tmax
Time to Observed maximum serum concentration
Measured: Up to day 71
Pharmacokinetics- AUC0-∞
Area under the serum concentration-time curve calculated from time zero to infinity
Measured: Up to day 71
Pharmacokinetics- AUC0-t
Area under the serum concentration-time curve calculated from time zero to the last measured time point
Measured: Up to day 71
Pharmacokinetics- T1/2
Terminal half-life (T1/2)
Measured: Up to day 71
Pharmacokinetics- CL/F
Apparent clearance of drug from serum when dosed subcutaneously
Measured: Up to day 71
Pharmacokinetics- Vz/F
Apparent volume of distribution when dosed subcutaneously during the terminal phase
Measured: Up to day 71
Pharmacokinetics- Anti-drug antibody
A measure of the body's immune response to CC-90006
Measured: Up to day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start21 Nov 2016
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934269
- Sponsor's protocol ID
- CC-90006-CP-001
- Status last verified
- Feb 2018
- First submitted
- 13 Oct 2016
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02934269
- Acronym / sponsor ID
- CC-90006-CP-001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy subjects, Safety, CC-90006, Phase 1, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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 a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy subjects.
Detailed description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending doses of CC-90006 in healthy subjects.
This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40 subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8 subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2 subjects).
Eligible subjects will check into the clinic site on the day before dosing (Day -1) and receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2), 22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be performed and blood samples will be collected for determination of levels of CC-90006 in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CC-90006; Dose Level 1 | Experimental | Drug: CC-90006CC-90006 will be administered by subcutaneous injection in the abdomen |
| CC-90006; Dose Level 2 | Experimental | Drug: CC-90006CC-90006 will be administered by subcutaneous injection in the abdomen |
| CC-90006; Dose Level 3 | Experimental | Drug: CC-90006CC-90006 will be administered by subcutaneous injection in the abdomen |
| CC-90006; Dose Level 4 | Experimental | Drug: CC-90006CC-90006 will be administered by subcutaneous injection in the abdomen |
| CC-90006; Dose Level 5 | Experimental | Drug: CC-90006CC-90006 will be administered by subcutaneous injection in the abdomen |
| Placebo | Experimental | Drug: PlaceboPlacebo will be administered by subcutaneous injection in the abdomen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, and a body mass index (BMI) of ≥ 18 and ≤ 33 kg/m2 with body weight ≥ 50 and ≤ 90 kg at screening.
- Females must have been surgically sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening).
Key exclusion criteria (4 listed)
- Exposure/treatment to an investigational (new chemical entity) or marketed drug or biologic within 30 days preceding the first dose administration, or five half-lives of that investigational drug or biologic, if known (whichever is longer).
- Donation blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.
- History of alcohol or drug abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol or drug screen.
- Vaccination within 30 days prior to the first dose administration or has plans to receive a vaccination during the course of the study (including the follow phone call on Day 105).
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| CC-90006 | Drug | CC-90006; Dose Level 1, CC-90006; Dose Level 2, CC-90006; Dose Level 3, CC-90006; Dose Level 4, CC-90006; Dose Level 5 |
Primary outcome
Adverse Events (AEs)
Time frame: Up to day 105
Number of participants with adverse events
8 secondary outcomes
Pharmacokinetics- Cmax
Time frame: Up to day 71
Pharmacokinetics- Tmax
Time frame: Up to day 71
Pharmacokinetics- AUC0-∞
Time frame: Up to day 71
Pharmacokinetics- AUC0-t
Time frame: Up to day 71
Pharmacokinetics- T1/2
Time frame: Up to day 71
Pharmacokinetics- CL/F
Time frame: Up to day 71
Pharmacokinetics- Vz/F
Time frame: Up to day 71
Pharmacokinetics- Anti-drug antibody
Time frame: Up to day 71
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 8 Feb 2018.
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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.
Leon Carayannopoulos, MD study director
Celgene Corporation
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-90006 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 2 inclusion and 4 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 8 Feb 2018. 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?
Adverse Events (AEs) (time frame: Up to day 105). 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 8 Feb 2018.