A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337345
• Other study ID #: IM042-003
• Status: Completed
• Phase: Phase 1
• Start date: May 2, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cendakimab
Specified Dose on Specified Days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials Llc	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Up to Day 105
Primary	Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))		Up to Day 105
Primary	AUC from time zero extrapolated to infinite time (AUC(INF))		Up to Day 105
Secondary	Number of participants with treatment emergent adverse events (TEAEs)		Up to Day 107
Secondary	Number of Participants with Adverse Events (AEs)		Up to Day 107
Secondary	Number of participants with clinical laboratory abnormalities		Up to Day 107
Secondary	Number of participants with vital sign abnormalities		Up to Day 107
Secondary	Number of participants with physical examination abnormalities		Up to Day 107
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 107
Secondary	Number of participants with concomitant medications		Up to Day 107
Secondary	Number of participants with concomitant procedures		Up to Day 107
Secondary	Time of maximum observed concentration (Tmax)		Up to Day 105
Secondary	Terminal half-life (T-HALF)		Up to Day 105
Secondary	Apparent total body clearance (CL/F)		Up to Day 105

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls