This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants
Healthy
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion Criteria: The participant is considered by the investigator to be in good health as determined by medical history, clinical laboratory test results (including urinalysis), physical and neurological examination, vital signs, and ECG. The participant agrees to comply with all protocol requirements. The participant is a healthy male or female 18 to 55 years of age, inclusive. The participant has body weight ≥50 kg and a BMI of 19 to 30 kg/m2, inclusive. Exclusion Criteria: The participant has a history of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTcF). The participant has a past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT interval syndrome prior to initial dosing. The participant has frequent headaches and/or migraine or recurrent nausea and/or vomiting (for vomiting only: more than twice a month). The participant has history of malignancy including solid tumors and hematologic malignancies within 5 years prior to the screening visit (except basal cell and squamous cell carcinomas of the skin that had been completely excised and were considered cured). The participant has a history of clinically significant drug or food allergies, as determined by the investigator.
Sites / Locations
- PPD Development, LPRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ABL301
Placebo
The single doses of ABL301 will be administered via IV infusion
The single doses of placebo will be administered via IV infusion.