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

NCT06462118 | Completed Phase 1 FDA Drug

• 1 other identifier: GP45400
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Relative bioavailability (F%) for thigh injection of astegolimab

  Approximately 85 days

• F% for upper arm injection of astegolimab

  Approximately 85 days

• Half-life (T1/2) of astegolimab

  Approximately 85 days

• 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

Study Arms (3)

Treatment A

EXPERIMENTAL

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

Drug: Astegolimab

Treatment B

EXPERIMENTAL

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

Drug: Astegolimab

Treatment C

EXPERIMENTAL

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

Drug: Astegolimab

Interventions

Astegolimab DRUG

Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening

You may not qualify if:

• 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)

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Covance Research Unit - Daytona

Daytona Beach, Florida, 32117, United States

Location

Covance Research Unit - Dallas

Dallas, Texas, 75247, United States

Location

Covance Clinical Research Unit, Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

astegolimab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 17, 2024
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)