RecruitingNCT07662057Updated Aug 25, 2026

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

A Phase 1 interventional study of AB102 and Placebo in Healthy Volunteers, sponsored by Arcus Biosciences, Inc.. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Arcus Biosciences, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy Volunteers

Keywords

AB102
Healthy Volunteer
MRGPRX2 inhibitor

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 130 participants (estimated)

Study arms

Experimental
SAD Part
Escalating single oral doses of AB102 will be given to participants
Drug: AB102
Experimental
SAD Part Placebo
Escalating single oral doses of placebo will be given to participants
Other: Placebo
Placebo comparator
MAD Part
Escalating multiple oral doses of AB102 will be given to participants
Drug: AB102
Placebo comparator
MAD Part Placebo
Escalating multiple oral doses of placebo will be given to participants
Other: Placebo

Interventions

DrugAB102
Administered orally as specified in the treatment arm
OtherPlacebo
Administered orally as specified in the treatment arm

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

Research Site
Groningen, Netherlands
Recruiting

References and documents

Individual participant data

Plan to share: Yes — 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

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07662057
Lead sponsor: Arcus Biosciences, Inc.
Responsible party: Sponsor
First posted: Jun 23, 2026
Start date: Jul 9, 2026
Primary completion: Dec 2026 (estimated)
Completion: Dec 2026 (estimated)
Last update: Aug 25, 2026

Study contacts

Medical Director

Contact

ClinicalTrialInquiry@arcusbio.com

+1-510-462-3330

Medical Director

study director · Arcus Biosciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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