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

Celgene

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Drug: CC-97489

Study type: Interventional

Funder types: Industry

Identifiers

NCT05099822

2019-003458-10 (EudraCT Number)

CC-97489-CP-001

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Administration of CC-97489

Experimental group

Treatment:

Drug: CC-97489

Administration of Placebo

Experimental group

Treatment:

Other: Placebo