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OpenTrials
Completed

NCT Number: NCT05337345

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials Llc

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cendakimab

Drug

Specified Dose on Specified Days

Other names: CC-93538, BMS-986355, RPC4046

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 105

  2. 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

  3. AUC from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 105

Secondary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs)

    Time frame: Up to Day 107

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 107

  3. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 107

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 107

  5. Number of participants with physical examination abnormalities

    Time frame: Up to Day 107

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 107

  7. Number of participants with concomitant medications

    Time frame: Up to Day 107

  8. Number of participants with concomitant procedures

    Time frame: Up to Day 107

  9. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 105

  10. Terminal half-life (T-HALF)

    Time frame: Up to Day 105

  11. Apparent total body clearance (CL/F)

    Time frame: Up to Day 105

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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