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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2022-12-15

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

Cendakimab

Intervention Type DRUG

Specified Dose on Specified Days

Part 2

Group Type EXPERIMENTAL

Cendakimab

Intervention Type DRUG

Specified Dose on Specified Days

Interventions

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Cendakimab

Specified Dose on Specified Days

Intervention Type DRUG

Other Intervention Names

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CC-93538 BMS-986355 RPC4046

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes