CC-99677
DrugCC-99677
NCT Number: NCT04958291
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy Japanese adult participants. This study will be placebo-controlled to appropriately characterize the safety and tolerability of CC-99677.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Collaborative Neuroscience Network, LLC, Long Beach, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must satisfy the following criteria to be enrolled in the study:
Exclusion criteria
The presence of any of the following will exclude a participant from enrollment:
a. Symptoms must have completely resolved and, based on Investigator assessment in consultation with the Sponsor's Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving IP.
CC-99677
Placebo
Time frame: From enrollment until at least 28 days after last dose of study treatment
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: Up to 48 hours after last dose of study treatment
Maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Time of maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Area under the plasma concentration-time curve within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Area under the plasma concentration-time curve from time zero to time ti within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Concentration at the end of a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Trough observed plasma concentration
Time frame: Up to 48 hours after last dose of study treatment
Apparent terminal phase half-life
Time frame: Up to 48 hours after last dose of study treatment
Apparent total body clearance
Time frame: Up to 48 hours after last dose of study treatment
Apparent volume of distribution of terminal phase
Time frame: Up to 48 hours after last dose of study treatment
Degree of fluctuation
Time frame: Up to 48 hours after last dose of study treatment
Average concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Ratio of Cmax at steady-state to Cmax after the first dose
Time frame: Up to 48 hours after last dose of study treatment
Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Time frame: Up to 48 hours after last dose of study treatment
Maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Time of maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Area under the plasma concentration-time curve within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Area under the plasma concentration-time curve from time zero to time ti within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Concentration at the end of a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Trough observed plasma concentration
Time frame: Up to 48 hours after last dose of study treatment
Apparent terminal phase half-life
Time frame: Up to 48 hours after last dose of study treatment
Degree of fluctuation
Time frame: Up to 48 hours after last dose of study treatment
Average concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Ratio of Cmax at steady-state to Cmax after the first dose
Time frame: Up to 48 hours after last dose of study treatment
Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Celgene
Industry
A Phase 1 Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC 99677 in Healthy Adult Japanese Subjects
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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