Healthy Volunteers
Conditions
Keywords
AB102, Healthy Volunteer, MRGPRX2 inhibitor
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).
Interventions
DRUGAB102
Administered orally as specified in the treatment arm
OTHERPlacebo
Administered orally as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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/
Design outcomes
Primary
| 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 |
Countries
Netherlands
Contacts
CONTACTMedical Director
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed