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NCT Number: NCT07662057

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

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).

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AB102

Drug

Administered orally as specified in the treatment arm

Placebo

Other

Administered orally as specified in the treatment arm

Primary outcomes

  1. Number of participants experiencing Adverse Events (AEs)

    Time frame: Up to 49 days

  2. Maximum observed plasma concentration (Cmax) for SAD and MAD Parts

    Time frame: Up to 28 days

  3. Time to attain maximum observed plasma concentration (tmax) for SAD and MAD Parts

    Time frame: Up to 28 days

  4. Terminal elimination half-life (t1/2) for SAD Part

    Time frame: Up to 28 days

  5. 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

  6. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24h) for SAD Part

    Time frame: Up to 28 days

  7. Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) for SAD Part

    Time frame: Up to 28 days

  8. Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) for MAD Part

    Time frame: Up to 28 days

  9. Accumulation ratio (Racc(Cmax))for MAD Part

    Time frame: Up to 28 days

  10. Accumulation ratio(Racc(AUCtau)) for MAD Part

    Time frame: Up to 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+1-510-462-3330

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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