Health Trials

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

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorArcus Biosciences, Inc.

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AB102

    Drug

    Administered orally as specified in the treatment arm

  • Placebo

    Other intervention

    Administered orally as specified in the treatment arm

Treatment groups

130 Participants
are divided into 4 treatment groups
Group A: SAD PartExperimental treatment 1 intervention
Group B: SAD Part PlaceboExperimental treatment 1 intervention
Group C: MAD PartPlacebo comparator 1 intervention
Group D: MAD Part PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arcus Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now