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

NCT07662057 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: ARC-102-1012026-526279-52-00
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Healthy Volunteers

Keywords

AB102; Healthy Volunteer; MRGPRX2 inhibitor

Outcome Measures

Primary Outcomes (10)

• Number of participants experiencing Adverse Events (AEs)

  Up to 49 days

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

  Up to 28 days

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

  Up to 28 days

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

  Up to 28 days

• Area under the plasma concentration-time curve from time 0 to last sample (AUClast) for SAD and MAD Parts

  Up to 28 days

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

  Up to 28 days

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

  Up to 28 days

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

  Up to 28 days

• Accumulation ratio (Racc(Cmax))for MAD Part

  Up to 28 days

• Accumulation ratio(Racc(AUCtau)) for MAD Part

  Up to 28 days

Study Arms (4)

SAD Part

EXPERIMENTAL

Escalating single oral doses of AB102 will be given to participants

Drug: AB102

SAD Part Placebo

EXPERIMENTAL

Escalating single oral doses of placebo will be given to participants

Other: Placebo

MAD Part

PLACEBO COMPARATOR

Escalating multiple oral doses of AB102 will be given to participants

Drug: AB102

MAD Part Placebo

PLACEBO COMPARATOR

Escalating multiple oral doses of placebo will be given to participants

Other: Placebo

Interventions

AB102 DRUG

Administered orally as specified in the treatment arm

MAD Part; SAD Part

Placebo OTHER

Administered orally as specified in the treatment arm

MAD Part Placebo; SAD Part Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

+1-510-462-3330; ClinicalTrialInquiry@arcusbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share