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

Phase 1TerminatedNCT05099822

Celgene84 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

CC-97489DRUG

Specified dose on specified days

PlaceboOTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Other protocol-defined inclusion/exclusion criteria apply

Locations (1)

Local Institution - 001

Leuven, Vlaams Brabant, Belgium

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: 28 days after the last dose

Incidence of Serious Adverse Events (SAEs)

Time frame: 28 days after the last dose

Number of participants with clinically significant changes in electrocardiogram parameters

Time frame: Day 21

Incidence of clinically significant changes in vital signs: Body temperature

Time frame: Day 21

Incidence of clinically significant changes in vital signs: Respiratory rate

Time frame: Day 21

Incidence of clinically significant changes in vital signs: Blood pressure

Time frame: Day 21

Incidence of clinically significant changes in vital signs: Heart rate

Time frame: Day 21

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Time frame: Day 18

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

Time frame: Day 18

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Time frame: Day 18

Secondary Outcomes

Pharmacokinetics - Maximum observed plasma concentration (Cmax)

Data from ClinicalTrials.gov

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