This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants

Description

This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.

Conditions

Healthy

Study Overview

Study Details

Study overview

This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.

A Phase 1 Randomized, A Phase 1 Randomized, Placebo Controlled, Double Blind, Two Part, Single- and Multiple-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered ABL301 in Healthy Adult Participants

This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Austin

PPD Development, LP, Austin, Texas, United States, 78744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * (MAD only) The participant has a current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C SSRS), or a lifetime suicide attempt.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

ABL Bio, Inc.,

Study Record Dates

2025-01