ABL301 for Healthy Subjects

Overseen By Sangmi Lee

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ABL Bio, Inc.

Disqualifiers: Cardiovascular disease, Malignancy, Psychiatric disorder, others

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Healthy adults aged 18-55, with a body weight of at least 50 kg and BMI between 19-30 kg/m2 can join this trial. They must be in good health based on medical history, lab tests, physical exams, vital signs, and ECG results. Participants should not have frequent headaches or migraines, any cancer within the last five years (except certain skin cancers), significant heart issues or allergies as determined by the investigator.

Inclusion Criteria

I weigh at least 50 kg and my BMI is between 19 and 30.

Participant agrees to comply with all protocol requirements

Participant is considered by the investigator to be in good health based on medical history, clinical tests, physical and neurological examination, vital signs, and ECG

Exclusion Criteria

I often have headaches, migraines, or I vomit more than twice a month.

I have a history of heart problems, including high blood pressure or irregular heartbeat.

I have not had any psychiatric disorders, suicidal thoughts in the last 6 months, or any suicide attempts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of ABL301 or placebo

16 weeks

Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of ABL301 or placebo

24 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• ABL301
• Placebo

Trial Overview The study is testing ABL301 against a placebo to evaluate its safety and how it's processed by the body (pharmacokinetics) and its effects on the body's response (pharmacodynamics). It's a first-in-human study where participants are randomly assigned to receive either ABL301 or placebo in single ascending doses (SAD) and multiple ascending doses (MAD).

Participant Groups

Group I: ABL301 Experimental Treatment 1 Intervention

The single doses of ABL301 will be administered via IV infusion

Group II: Placebo Placebo Group 1 Intervention

The single doses of placebo will be administered via IV infusion.

Who Is Running the Clinical Trial?

ABL Bio, Inc.

Lead Sponsor

Trials

6

Recruited

390+