ClinicalTrials.gg
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

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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).

02

Conditions studied

  • Healthy Volunteers

Keywords

  • AB102
  • Healthy Volunteer
  • MRGPRX2 inhibitor
03

In context

Lead sponsor

Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Understands the study procedures in the Form and is willing and able to comply with the protocol.
  • : 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 that may be used throughout the study.
  • Good physical and mental health based on medical history, physical examination, clinical laboratory, , 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 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- 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.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Research Site
    Groningen, Netherlands
    Recruiting
08

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

Data sharing details ↗ · trials.arcusbio.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jun 23, 2026
StartActual
Jul 9, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07662057
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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