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Monoclonal Antibodies

Astegolimab for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening
Be between 18 and 65 years old
Must not have
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
History of immunodeficiency, including but not limited to, human immunodeficiency virus (HIV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 85 days
Awards & highlights

Summary

"This trial aims to understand how astegolimab works in the body when injected under the skin in different body areas of healthy individuals."

Who is the study for?
This trial is for healthy individuals who are interested in participating in a study to understand how a drug behaves in the body. Specific eligibility criteria details were not provided.
What is being tested?
The focus of this study is on astegolimab, which will be injected into different parts of the body (abdomen, thigh, or upper arm) to see if the location affects how the drug works.
What are the potential side effects?
Since this trial involves healthy subjects and astegolimab administration, potential side effects may include reactions at the injection site such as pain, redness or swelling. Other risks are not detailed but can vary based on individual response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 50kg and 110kg, and my BMI is between 18.0 and 30.0.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had major surgery in the last 28 days and don't expect to need any during the study.
Select...
I have a history of immunodeficiency or HIV.
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I have had active or untreated latent tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC extrapolated to infinity (AUC0-infinity) of astegolimab
Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab
Maximum serum concentration (Cmax) of astegolimab
Secondary outcome measures
Apparent systemic clearance (CL/F) of astegolimab
Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab
F% for upper arm injection of astegolimab
+4 more

Side effects data

From 2021 Phase 2 trial • 396 Patients • NCT04386616
8%
Constipation
7%
Hypokalaemia
7%
Anaemia
6%
Hypertension
5%
Headache
5%
COVID-19 pneumonia
5%
Hypotension
4%
Anxiety
3%
Dry skin
3%
Respiratory failure
2%
Acute kidney injury
2%
Pneumonia
2%
Gastric ulcer haemorrhage
2%
Multiple organ dysfunction syndrome
2%
Pneumothorax
2%
Nausea
2%
Hypoxia
2%
Atrial fibrillation
2%
Acute myocardial infarction
2%
COVID-19
2%
Septic shock
1%
Right ventricular dysfunction
1%
Renal impairment
1%
Pleural effusion
1%
Pneumomediastinum
1%
Pulmonary embolism
1%
Respiratory arrest
1%
Radius fracture
1%
Confusional state
1%
Cardiac failure
1%
Toxic encephalopathy
1%
Haematuria
1%
Shock haemorrhagic
1%
Left ventricular failure
1%
Liver injury
1%
Urinary tract infection
1%
Pneumonia bacterial
1%
Aspartate aminotransferase increased
1%
Urosepsis
1%
Uterine leiomyoma
1%
Pneumonia aspiration
1%
Respiratory distress
1%
Shock
1%
Cardiac arrest
1%
Oxygen saturation decreased
1%
Hypernatraemia
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
MSTT1041A
UTTR1147A

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment CExperimental Treatment1 Intervention
Participants will receive one subcutaneous (SC) dose in the upper arm.
Group II: Treatment BExperimental Treatment1 Intervention
Participants will receive one subcutaneous (SC) dose in the thigh.
Group III: Treatment AExperimental Treatment1 Intervention
Participants will receive one subcutaneous (SC) dose in the abdomen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Astegolimab
2021
Completed Phase 2
~1440

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,542 Previous Clinical Trials
567,999 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
890,228 Total Patients Enrolled
~52 spots leftby Apr 2025
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