Healthy Volunteers
Conditions
Brief summary
The main objective is to study how astegolimab may behave in the body when injected subcutaneously into the abdomen, thigh, or upper arm in healthy participants.
Interventions
DRUGAstegolimab
Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening
Exclusion criteria
* History of significant hypersensitivity or severe allergic reaction, including anaphylaxis, to any drug compound, food, or other substance * Any immunization or vaccination 14 days prior to the Check-in (Day -1) or plans to obtain any immunization or vaccination within 30 days after the Check-in * Any surgical procedure (except for minor surgeries) within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * Donation of blood from 30 days prior to screening through study completion or end of trial, inclusive, or of plasma from 2 weeks prior to screening through study completion or end of trial, inclusive * History of immunodeficiency, including but not limited to, human immunodeficiency virus (HIV) infection * History of active or untreated latent tuberculosis * History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer * Unstable cardiac disease, myocardial infarction, or New York Heart Association Class 3 or 4 heart failure within 12 months prior to screening * History or presence of clinically significant ECG abnormalities at screening or check-in (Day -1) * Positive for Hepatitis B or Hepatitis C (HCV) * Tattoo(s) or scarring at or near the site of injection (abdomen, front and middle thigh, or upper arm) or any other condition which may interfere with the injection site examination (as determined by the Investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab | Approximately 85 days |
| AUC extrapolated to infinity (AUC0-infinity) of astegolimab | Approximately 85 days |
| Maximum serum concentration (Cmax) of astegolimab | Approximately 85 days |
Secondary
| Measure | Time frame |
|---|---|
| Apparent systemic clearance (CL/F) of astegolimab | Approximately 85 days |
| Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab | Approximately 85 days |
| F% for upper arm injection of astegolimab | Approximately 85 days |
| Incidence of anti-drug antibodies (ADAs) | Approximately 85 days |
| Time to maximum serum concentration (Tmax) of astegolimab | Approximately 85 days |
| Half-life (T1/2) of astegolimab | Approximately 85 days |
| Relative bioavailability (F%) for thigh injection of astegolimab | Approximately 85 days |
Countries
United States
Outcome results
None listed