RecruitingPhase 1ACTRN12625000212459

Phase 1 Study to Investigate ABS-101 in Healthy Adult Participants

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 First-in-Human Study of Single Ascending Doses of ABS-101 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adult Participants


Sponsor

Absci Pty Ltd

Enrollment

40 participants

Start Date

May 12, 2025

Study Type

Interventional

Conditions

Summary

A first-in-human, single-ascending dose study to determine the safety, tolerability, pharmacokinetics (PD) and pharmacodynamics (PD) of ABS-101 in healthy adult participants. Results of the study will be used to determine the starting dose for subsequent studies in either healthy volunteers and/or patients. As this is a study in healthy volunteers to evaluate safety and tolerability there is not study hypothesis to evaluate.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

ABS-101 is a new experimental biologic medication being developed as a potential treatment for inflammatory conditions. Before it can be tested in patients, its safety and how the body processes it need to be carefully studied in healthy volunteers — this is called a first-in-human study. This Phase 1 trial will test single and then gradually increasing doses of ABS-101 in healthy adults to find out how well it is tolerated, what dose levels are safe, and how the body absorbs, distributes, and eliminates it. The results will guide the dose used in future patient trials. Participants will have vital signs, blood tests, and ECGs monitored throughout. You may be eligible if you are a healthy adult aged 18 to 65 with a BMI of 18–32, weigh at least 60 kg, and test negative for drug use, alcohol, and nicotine. People with liver conditions, HIV, hepatitis B or C, or who are pregnant, are not eligible. Since the medication targets the immune pathway TL1A, prior exposure to any anti-TL1A therapy also disqualifies participation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study evaluates the single-dose administration of ABS-101 or matched placebo, administered subcutaneously (SC) at 4 dose levels (150, 300, 600 and 1000 mg) and intravenously (IV) at 1 dose level

This study evaluates the single-dose administration of ABS-101 or matched placebo, administered subcutaneously (SC) at 4 dose levels (150, 300, 600 and 1000 mg) and intravenously (IV) at 1 dose level at 300 mg which will be in parallel with the 1000 mg SC dose.. Each cohort will consist of 8 participants who will each receive a single dose of investigational drug or matched placebo. Healthy volunteers will stay in the clinical research unit for a period of 4 days in total, including admission on the day before dosing, and 3 days observation following administration of study intervention. Each of the cohorts will be followed-up afterwards for safety. Safety, tolerability, and available PK data will be reviewed by the Safety Review Committee (SRC) for dose escalation by evaluating adverse events and laboratory values.


Locations(1)

Nucleus Network - Melbourne

VIC, Australia

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ACTRN12625000212459


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