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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, Single Dose Study to Evaluate the Effect of Injection Site on the Pharmacokinetics of Astegolimab in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462118
• Other study ID #: GP45400
• Status: Recruiting
• Phase: Phase 1
• Start date: June 17, 2024
• Est. completion date: April 4, 2025

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GP45400 https://forpatients.roche.com
• Phone: 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: April 4, 2025
• Est. primary completion date: April 4, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Covance Research Unit - Dallas	Dallas	Texas
United States	Covance Research Unit - Daytona	Daytona Beach	Florida
United States	Covance Clinical Research Unit, Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab		Approximately 85 days
Primary	AUC extrapolated to infinity (AUC0-infinity) of astegolimab		Approximately 85 days
Primary	Maximum serum concentration (Cmax) of astegolimab		Approximately 85 days
Secondary	Relative bioavailability (F%) for thigh injection of astegolimab		Approximately 85 days
Secondary	F% for upper arm injection of astegolimab		Approximately 85 days
Secondary	Half-life (T1/2) of astegolimab		Approximately 85 days
Secondary	Apparent systemic clearance (CL/F) of astegolimab		Approximately 85 days
Secondary	Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab		Approximately 85 days
Secondary	Time to maximum serum concentration (Tmax) of astegolimab		Approximately 85 days
Secondary	Incidence of anti-drug antibodies (ADAs)		Approximately 85 days