Healthy VolunteersPhase 1NCT05337345
A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
A Phase 1 study testing Cendakimab in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants. 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?
- Cendakimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 15 Dec 2022
- 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 participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2
- Body weight ≥40.0 kg
Who cannot join
- History of clinically significant infection within 4 weeks of dosing on Day 1
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- History of clinically significant allergic reaction to any drug, biologic, food or vaccine
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials Llc
Anaheim, California, 92801
About this study
Official title: A Phase I, Open-Label, Randomized, Two-part Parallel Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Cendakimab Administered Using Autoinjector Versus Using Prefilled Syringe, and to Evaluate the Pharmacokinetics of Cendakimab When Administered by Autoinjector at Different Injection Sites, in Healthy Participants
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- Cendakimab
- Keywords
- Pharmacokinetics, Cendakimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CendakimabDrug
Also called CC-93538, BMS-986355, RPC4046
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: Cendakimab |
| Part 2 | Experimental | Not described Receives: Drug: Cendakimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to Day 105
Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 105
AUC from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 105
Secondary outcomes (11)
Number of participants with treatment emergent adverse events (TEAEs)
Measured: Up to Day 107
Number of Participants with Adverse Events (AEs)
Measured: Up to Day 107
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 107
Number of participants with vital sign abnormalities
Measured: Up to Day 107
Number of participants with physical examination abnormalities
Measured: Up to Day 107
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 107
Number of participants with concomitant medications
Measured: Up to Day 107
Number of participants with concomitant procedures
Measured: Up to Day 107
Time of maximum observed concentration (Tmax)
Measured: Up to Day 105
Terminal half-life (T-HALF)
Measured: Up to Day 105
Apparent total body clearance (CL/F)
Measured: Up 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 posted20 Apr 2022
- Study start2 May 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- 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
- NCT05337345
- Sponsor's protocol ID
- IM042-003
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhang P, De Oliveira CHMC, Yu K, Basdeo S, Charriez CM, Syto M, Thomas M, Murthy B. Pharmacokinetic Characterization of Cendakimab Administered with Different Devices and at Different Injection Sites in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2025 Jul;50(4):307-317. doi: 10.1007/s13318-025-00949-0. Epub 2025 May 15.
PubMed 40374841
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized, Two-part Parallel Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Cendakimab Administered Using Autoinjector Versus Using Prefilled Syringe, and to Evaluate the Pharmacokinetics of Cendakimab When Administered by Autoinjector at Different Injection Sites, in Healthy Participants
- ClinicalTrials.gov ID
- NCT05337345
- Acronym / sponsor ID
- IM042-003
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Cendakimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 20 Apr 2022 (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.
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Cendakimab |
| Part 2 | Experimental | Drug: Cendakimab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2
- Body weight ≥40.0 kg
Key exclusion criteria (4 listed)
- History of clinically significant infection within 4 weeks of dosing on Day 1
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- History of clinically significant allergic reaction to any drug, biologic, food or vaccine
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| CendakimabAlso: CC-93538, BMS-986355, RPC4046Specified Dose on Specified Days | Drug | Part 1, Part 2 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to Day 105
Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 105
AUC from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 105
11 secondary outcomes
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to Day 107
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 107
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 107
Number of participants with vital sign abnormalities
Time frame: Up to Day 107
Number of participants with physical examination abnormalities
Time frame: Up to Day 107
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 107
Number of participants with concomitant medications
Time frame: Up to Day 107
Number of participants with concomitant procedures
Time frame: Up to Day 107
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 105
Terminal half-life (T-HALF)
Time frame: Up to Day 105
Apparent total body clearance (CL/F)
Time frame: Up 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 10 Feb 2023.
- Derived from this study: PubMed 40374841Zhang P, De Oliveira CHMC, Yu K, Basdeo S, Charriez CM, Syto M, Thomas M, Murthy B. Pharmacokinetic Characterization of Cendakimab Administered with Different Devices and at Different Injection Sites in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2025 Jul;50(4):307-317. doi: 10.1007/s13318-025-00949-0. Epub 2025 May 15.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 Cendakimab in people with Healthy Volunteers, run by Bristol-Myers Squibb 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 3 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 10 Feb 2023. 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?
Maximum observed concentration (Cmax) (time frame: Up to Day 105). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337345, which also lists 1 linked publication.
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 10 Feb 2023.