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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05337345
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
7.9
Anticipated Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 2, 2022
Anticipated Primary Completion Date :
Dec 27, 2022
Anticipated Study Completion Date :
Dec 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1

Drug: Cendakimab
Specified Dose on Specified Days
Other Names:
  • CC-93538
  • BMS-986355
  • RPC4046

    		•
    Experimental: Part 2

    Drug: Cendakimab
    Specified Dose on Specified Days
    Other Names:
  • CC-93538
  • BMS-986355
  • RPC4046

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed concentration (Cmax) [Up to Day 105]

    2. Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to Day 105]

    3. AUC from time zero extrapolated to infinite time (AUC(INF)) [Up to Day 105]

    Secondary Outcome Measures

    1. Number of participants with treatment emergent adverse events (TEAEs) [Up to Day 107]

    2. Number of Participants with Adverse Events (AEs) [Up to Day 107]

    3. Number of participants with clinical laboratory abnormalities [Up to Day 107]

    4. Number of participants with vital sign abnormalities [Up to Day 107]

    5. Number of participants with physical examination abnormalities [Up to Day 107]

    6. Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 107]

    7. Number of participants with concomitant medications [Up to Day 107]

    8. Number of participants with concomitant procedures [Up to Day 107]

    9. Time of maximum observed concentration (Tmax) [Up to Day 105]

    10. Terminal half-life (T-HALF) [Up to Day 105]

    11. Apparent total body clearance (CL/F) [Up to Day 105]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaheim Clinical Trials Llc Anaheim California United States 92801

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05337345
    Other Study ID Numbers:
    • IM042-003
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    May 16, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Pharmacokinetics
    Cendakimab

    Study Results

    No Results Posted as of May 16, 2022