Clinical trial NCT05337345: A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Cendakimab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to Day 105
measure: Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 105
measure: AUC from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to Day 105
Secondary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAEs)
timeFrame: Up to Day 107
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 107
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 107
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 107
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 107
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 107
measure: Number of participants with concomitant medications
timeFrame: Up to Day 107
measure: Number of participants with concomitant procedures
timeFrame: Up to Day 107
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to Day 105
measure: Terminal half-life (T-HALF)
timeFrame: Up to Day 105
measure: Apparent total body clearance (CL/F)
timeFrame: Up to Day 105
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: