A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Astegolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06462118

GP45400

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Treatment A

Experimental group

Description:

Participants will receive one subcutaneous (SC) dose in the abdomen.

Treatment:

Drug: Astegolimab

Treatment B

Experimental group

Description:

Participants will receive one subcutaneous (SC) dose in the thigh.

Treatment:

Drug: Astegolimab

Treatment C

Experimental group

Description:

Participants will receive one subcutaneous (SC) dose in the upper arm.

Treatment:

Drug: Astegolimab