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
Absci Pty Ltd
40 participants
May 12, 2025
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
Inclusion Criteria5
- Must be capable of giving a signed informed consent
- Participants in good health based on medical history, physical examinations, vital signs, 12-lead ECGs, clinical laboratory tests as determined by the Investigator
- Body Mass Index (BMI) within the range 18 to 32 kg/m2 (inclusive), and total body weight more than 60 kg
- Adhere to highly effective contraception or are proven post-menopausal or unable to bear children.
- Must have negative drug, nicotine and alcohol test results.
Exclusion Criteria6
- Any clinical significant abnormalities in laboratory test results or diagnostic assessments deemed clinically significant by the investigator
- History of liver diseases, Gilbert’s syndrome, or abnormal liver function
- Exposure to anti-TL1A or any anti-TL1A therapy
- Positive pregnancy test at Screening, Day -1 and throughout study
- Positive serology test for HIV, Hepatitis B or Hepatitis C
- Pre-existing ADA against ABS-101 at Screening
Interested in this trial?
Get notified about updates and connect with the research team.
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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12625000212459