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Not yet recruiting NCT07662057

A Study to Investigate the Safety, Tolerability, and PK of AB102 in Healthy Participants

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AB102, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-Blind, Randomized, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AB102 in Healthy Participants

Overview

The purpose of this study is assess the safety and tolerability of AB102 and characterize the pharmacokinetics (PK) profile of AB102 after single and multiple ascending oral dose(s).

Interventions

  • Drug AB102
    Administered orally as specified in the treatment arm
  • Other Placebo
    Administered orally as specified in the treatment arm

Primary outcome measures

  • Number of participants experiencing Adverse Events (AEs) [Time frame: Up to 49 days]
  • Maximum observed plasma concentration (Cmax) for SAD and MAD Parts [Time frame: Up to 28 days]
  • Time to attain maximum observed plasma concentration (tmax) for SAD and MAD Parts [Time frame: Up to 28 days]
  • Terminal elimination half-life (t1/2) for SAD Part [Time frame: Up to 28 days]
  • Area under the plasma concentration-time curve from time 0 to last sample (AUClast) for SAD and MAD Parts [Time frame: Up to 28 days]
  • Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24h) for SAD Part [Time frame: Up to 28 days]
  • Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) for SAD Part [Time frame: Up to 28 days]
  • Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) for MAD Part [Time frame: Up to 28 days]
  • Accumulation ratio (Racc(Cmax))for MAD Part [Time frame: Up to 28 days]
  • Accumulation ratio(Racc(AUCtau)) for MAD Part [Time frame: Up to 28 days]

Eligibility criteria

Inclusion criteria

  • Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
  • BMI: 19.0 to 30.0 kg/m2, inclusive, at screening.
  • All prescribed medication must have been stopped at least 30 days prior to admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.
  • Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, vital signs, and complete neurological examination, as judged by the Investigator.
  • Participants must follow protocol-specified contraception guidance.

Exclusion criteria

  • Have a history of relevant atopy, drug hypersensitivity and/or food allergies.
  • Using tobacco products within 3 months prior to the screening.
  • Have a significant infection or known inflammatory process on screening or admission.
  • Have received any vaccination within 14 days of admission date for non-live vaccines or 28 days of admission date for live attenuated vaccines.
  • History of alcohol abuse or drug addiction in the last 2 years (including soft drugs like cannabis products).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07662057 · ARC-102-101 · 2026-526279-52-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗