Healthy ParticipantsPhase 1NCT05638282
A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants
A Phase 1 study testing Cendakimab in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese 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 Participants
- What is being tested?
- Cendakimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 27 Jun 2023
- 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
- Participants must be Chinese (both biological parents are ethnically Chinese).
- Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m^2), inclusive. BMI = weight (kg)/[height (m)]^2.
- Body weight ≥ 50.0 kg.
Who cannot join
- History of clinically significant infection within 4 weeks of dosing on Day 1.
- Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants
The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.
- Conditions
- Healthy Participants
- Being tested
- Cendakimab, Placebo
- Keywords
- Healthy, Chinese, 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
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cendakimab | Experimental | Not described Receives: Drug: Cendakimab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Measured: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Measured: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
Measured: Predose and at multiple timepoints (up to 105 days) after dosing
Secondary outcomes (5)
Number of Participants with Treatment-emergent Adverse Events
Measured: Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Measured: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Physical Examinations
Measured: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Electrocardiograms
Measured: Screening (Days -28 to -1) through Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Feb 2023
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 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
- NCT05638282
- Sponsor's protocol ID
- IM042-005
- Status last verified
- Jul 2023
- First submitted
- 30 Nov 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants
- ClinicalTrials.gov ID
- NCT05638282
- Acronym / sponsor ID
- IM042-005
- Conditions
- Healthy Participants
- Keywords
- Healthy, Chinese, Cendakimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 6 Dec 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 assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cendakimab | Experimental | Drug: Cendakimab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be Chinese (both biological parents are ethnically Chinese).
- Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m^2), inclusive. BMI = weight (kg)/[height (m)]^2.
- Body weight ≥ 50.0 kg.
Key exclusion criteria (4 listed)
- History of clinically significant infection within 4 weeks of dosing on Day 1.
- Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator.
- 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 | Cendakimab |
| PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Time frame: Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
Time frame: Predose and at multiple timepoints (up to 105 days) after dosing
5 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events
Time frame: Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Physical Examinations
Time frame: Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Electrocardiograms
Time frame: Screening (Days -28 to -1) through 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 1 Aug 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Participants, run by Bristol-Myers Squibb at 1 site in China.
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 1 Aug 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 China. 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. Some participants in this study may receive a placebo. 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 Serum Concentration (Cmax) (time frame: Predose and at multiple timepoints (up to 105 days) after dosing). 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?
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 1 Aug 2023.