Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ANB033 - Part 1c
| ISRCTN | ISRCTN90323813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90323813 |
| Integrated Research Application System (IRAS) | 1013483 |
| Protocol Number | ANB033-101 |
| Sponsor | AnaptysBio, Inc. |
| Funder | AnaptysBio, Inc. |
- Submission date
- 18/01/2026
- Registration date
- 27/01/2026
- Last edited
- 26/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
AnaptysBio, Inc. is developing the study treatment ANB033 as a potential new treatment for autoimmune and inflammatory diseases such as eosinophilic esophagitis (EoE). Thesediseases appear to be the result of an overreaction of a person’s immune system which damages their own cells or organs.
ANB033 is an investigational monoclonal antibody, designed to reduce disease-causing immune cells and restore healthy immune balance. It is given by an injection under the skin. The purpose of this research study is to investigate ANB033 safety and tolerability when given to adult participants with symptomatic EoE and how this treatment is absorbed and processed by the human body.
Who can participate?
Part 1c of the study will enroll male and female participants ages 18 to 70 with a diagnosis of EoE.
What does the study involve?
Participants will be randomized to subcutaneous ANB033 or placebo in a 1:1 ratio, like flipping a coin.
What are the possible benefits and risks of participating?
Participation in this study may help develop important scientific knowledge that could contribute to the development of ANB033 as a potential new treatment for autoimmune and inflammatory diseases, potentially benefiting others in the future.
Where is the study run from?
This is a global study with clinical sites in Australia, Belgium, Canada, Finland, Germany, Italy, Netherlands, New Zealand, Norway, Spain, and the UK.
When is the study starting and how long is it expected to run for?
Part 1c is planned to start January 2026. The final participant’s last visit is projected to be in November 2027.
Who is funding the study?
AnaptysBio (USA)
Who is the main contact?
Mark Rigby, MD, PhD, clinicaltrialinfo@anaptysbio.com
Contact information
Principal investigator
87 Ipswich Road, QLD
Woolloongabba
4102
Australia
| Phone | +61 0432491089 |
|---|---|
| robertand@jmclinical.com |
Public
AnaptysBio, Inc.
10770 Wateridge Circle, Suite 210, CA
San Diego
92121
United States of America
| Phone | +1 (0)4042746330 |
|---|---|
| clinicaltrialinfo@anaptysbio.com |
Scientific
AnaptysBio, Inc.
10770 Wateridge Circle, Suite 210, CA
San Diego
92121
United States of America
| Phone | +1 (0)4042746330 |
|---|---|
| clinicaltrialinfo@anaptysbio.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Safety | |
| Scientific title | A phase 1, randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ANB033 in adult participants- part 1c | |
| Study objectives | Part 1c of the study will comprise a multicenter, double-blind, randomized, placebo-controlled, parallel arm design that compares the safety and tolerability of multiple SC (subcutaneous) doses of ANB033 versus placebo in participants with with symptomatic Eosinophilic Esophagitis (EoE). | |
| Ethics approval(s) |
Approved 16/01/2026, Bellberry Human Research Ethics Committee (123 Glen Osmond Road, Eastwood, Adelaide, 5063, Australia; +61 (0)883613222; bellberry@bellberry.com.au), ref: 2024-11-1935-A-10 | |
| Health condition(s) or problem(s) studied | Eosinophilic Esophagitis (EoE) | |
| Intervention | Part 1c of the study will comprise of a multicenter, double-blind, randomized, placebo-controlled, parallel arm design that compares the safety and tolerability of a single SC (subcutaneous) dose level of ANB033 or placebo in participants with symptomatic Eosinophilic Esophagitis (EoE). Part 1c will enroll participants every 2 weeks for 12 weeks for a total of 6 doses. Participants will be randomized to subcutaneous ANB033 or placebo in a 1:1 ratio. | |
| Intervention type | Drug | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(s) | ANB033 | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 22/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Male or female aged 18 to 70 years old 2. Willing and able to provide informed consent 3. Female participants must not be pregnant or lactating 4. Male participants must be willing to comply with protocol contraceptive requirements 5. Prior histologic documentation of EoE diagnosis 6. Absence of histologic response to at least 6 weeks of proton pump inhibitors (PPI) or documented intolerance to PPI. 7. Histologic evidence of EoE with peak eosinophil count ≥15/hpf, from 2 of 3 levels of the esophagus at the Screening endoscopy. 8. History of at least 4 episodes of dysphagia in the 2 weeks prior to Screening. 9. Willing to comply with necessary tests and protocol requirements |
| Key exclusion criteria | 1. Has signs, symptoms, or current diagnosis of concerning, severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, GI, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 2. Participant has a BMI of <16 or >35 kg/m² or total body weight <45 kg (99 lb) (Note: BMI = weight (kg)/[height (m)]²). 3. Participant smokes cigarettes or has quit smoking within 3 months of screening. 4. History of clinically significant drug or alcohol abuse 5. Clinically significant, abnormal 12-lead ECG 6. Planned surgery within 4 weeks prior to the start of screening 7. History of drug allergy, suspected medical condition, including autoimmune or inflammatory conditions, that currently requires or may require systemic immunomodulatory or immune suppressive therapy. 8. Predisposed to develop an infection 9. Positive for hepatitis B, hepatitis C and HIV-1 or HIV-2 antibodies 10. Diagnosis of, suspected diagnosis of, or concerns of acquiring active TB or currently with untreated latent TB. |
| Date of first enrolment | 28/02/2026 |
| Date of final enrolment | 28/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Australia
- Belgium
- Canada
- Germany
- Italy
- Netherlands
- Norway
- Spain
- United States of America
Study participating centre
Liverpool
L7 8XP
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
26/01/2026: Trial's existence confirmed by Bellberry Human Research Ethics Committee.
