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Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants

NCT ID: NCT05099822

Last Updated: 2023-12-14

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2022-07-11

Brief Summary

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This study aims to evaluate the safety, tolerability, of CC-97489

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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CC-97489 Healthy Adult Phase1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Administration of CC-97489

Group Type EXPERIMENTAL

CC-97489

Intervention Type DRUG

Specified dose on specified days

Administration of Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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CC-97489

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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BMS-986368

Eligibility Criteria

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Inclusion Criteria

* In good health, as determined by the investigator based on past medical history, physical examination, vital signs and clinical laboratory safety tests at screening.
* Body mass index (BMI) ≥ 18 and ≤ 33 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2

Exclusion Criteria

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 001

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2019-003458-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-97489-CP-001

Identifier Type: -

Identifier Source: org_study_id