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Monoclonal Antibodies

Astegolimab for Healthy Subjects

Phase 1
Waitlist Available
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 up to 5 years
Awards & highlights
No Placebo-Only Group

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.
Select...
I have had active or untreated latent tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,555 Previous Clinical Trials
569,222 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,313 Total Patients Enrolled
~43 spots leftby Apr 2025
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