A First-in-human Phase 1 Study to Investigate the Safety, Tolerability, and PK of AB102 in Healthy Participants

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AB102; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Director; Phone Number: +1-510-462-3330; Email: ClinicalTrialInquiry@arcusbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Part; Escalating single oral doses of AB102 will be given to participants	Drug: AB102; Administered orally as specified in the treatment arm
Experimental: SAD Part Placebo; Escalating single oral doses of placebo will be given to participants	Other: Placebo; Administered orally as specified in the treatment arm
Placebo Comparator: MAD Part; Escalating multiple oral doses of AB102 will be given to participants	Drug: AB102; Administered orally as specified in the treatment arm
Placebo Comparator: MAD Part Placebo; Escalating multiple oral doses of placebo will be given to participants	Other: Placebo; Administered orally as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Investigators: Study Director: Medical Director, Arcus Biosciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; AB102; MRGPRX2 inhibitor
• Other Study ID Numbers: ARC-102-101; 2026-526279-52-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, SAP, CSR) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, visit: https://trials.arcusbio.com/our-transparency-policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No