Evaluating the safety and effects of ABL301 in healthy adults

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 study is testing a new drug called ABL301 in healthy adults to see if it's safe and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: ABL Bio, Inc. (Industry-sponsored)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT05756920 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ABL301 administered intravenously to healthy adult participants. The study consists of two parts: a single ascending dose (SAD) phase where participants receive varying doses of ABL301 or a placebo, and a multiple ascending dose (MAD) phase with additional dosing. The trial will involve random assignment of participants to ensure unbiased results and will monitor health outcomes closely to determine the drug's profile in humans.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 years with a body weight of at least 50 kg and a BMI between 19 and 30.

Not a fit: Patients with a history of cardiovascular disease or significant ECG abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of ABL301, potentially leading to new treatment options.

How similar studies have performed: While this is a first-in-human study for ABL301, similar studies evaluating new drugs in healthy participants have shown success in establishing safety and dosing profiles.

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.
* (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.

Where this trial is running

Austin, Texas

• PPD Development, LP — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Dayoung Ok

Conditions Healthy