Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ANB033 - Part 1b
| ISRCTN | ISRCTN16318446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16318446 |
| EudraCT/CTIS number | 2024-520409-38-00 |
| Secondary identifying numbers | ANB033-101 |
- Submission date
- 10/07/2025
- Registration date
- 04/09/2025
- Last edited
- 03/09/2025
- 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 celiac disease (CeD). These diseases 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 subcutaneous injection.
The purpose of this research study is to investigate ANB033 safety and tolerability when given to adult participants with CeD and how this treatment is absorbed and processed by the human body.
Who can participate?
Adults aged 18-70 years old with CeD
What does the study involve?
This study is testing the safety, tolerability of both single and multiple doses of a new experimental treatment called ANB033.
What are the possible benefits and risks of participating?
ANB033 is an experimental medication so the risks to human participants have not been fully evaluated.
The benefits, risks and side effects that may occur in participants treated with ANB033 are based on the results from nonclinical investigations of ANB033 and information available from the same class of compound effects.
Where is the study run from?
Australia, New Zealand and the Netherlands
When is the study starting and how long is it expected to run for?
October 2024 to July 2026
Who is funding the study?
AnaptysBio, Inc. (USA)
Who is the main contact?
clinicaltrialinfo@anaptysbio.com
Contact information
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 |
Principal Investigator
Level 2, 97 Grafton Road, Grafton
Grafton Auckland
1010
New Zealand
| Phone | (+649) 303-4987 |
|---|---|
| tina@optimalclinicaltrials.com |
Principal Investigator
Suite 9, 6/230 Blackshaws Road, VIC
Altona North
3025
Australia
| Phone | +61 (0)1300903512 |
|---|---|
| owalsh@altonaclinicalresearch.com |
Study information
| Study design | Multicenter double-blind randomized placebo-controlled parallel-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other, Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A Phase I, randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ANB033 in adult participants - Part 1b |
| Study objectives | Part 1b 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 celiac disease (CeD). Exploratory assessments of the effect of ANB033 on gastrointestinal (GI) symptoms and on intestinal histology will be conducted. |
| Ethics approval(s) |
1. Approved 21/01/2025, Bellberry Human Research Ethics Committee (123 Glen Osmond Road Eastwood, Adelaide, 5063, Australia; +61 (0)883613222; bellberry@bellberry.com.au), ref: 2024-11-1935 2. Approved 25/03/2025, Southern Health and Disability Ethics Committee (Ministry of Health, PO Box 5013, Wellington, 6140, New Zealand; +64 (0)800 855 066; hdecs@health.govt.nz), ref: 2025 FULL 21884 |
| Health condition(s) or problem(s) studied | Celiac disease |
| Intervention | Part 1b of the study will comprise 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 CeD. Part 1b will enroll adults with CeD every 2 weeks for a total of three doses. Part 1b of the study will enroll adults with CeD. Participants will be randomized to subcutaneous ANB033 or placebo in a 1:1 ratio. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Pharmacodynamic |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | ANB033 |
| Primary outcome measure | The safety and tolerability of ANB033 in participants with celiac disease: 1. Incidence, type, and severity of all adverse events (AEs) recorded at Days 1, 15, 29, 36, 43, 57, 71, 85, 99, 127, 155, and 183 2. Vital signs, ECGs, physical examinations, and clinical laboratory assessments measured at Days 1, 15, 29, 36, 43, 57, 71, 85, 99, 127, 155, and 183 |
| Secondary outcome measures | 1. Pharmacokinetic (PK) parameters measured using a fully validated ligand-binding assay and noncompartmental analysis at Days 1, 15, 29, 36, 43, 57, 85, 99, 127 2. Incidence of confirmed positive anti-drug antibodies (ADAs) and titers measured using a fully validated ligand-binding assay at Days, 1, 15, 29, 36, 43, 57, 71, 85, 127 |
| Overall study start date | 30/10/2024 |
| Completion date | 01/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 60 |
| 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. Have an established diagnosis of Celiac Disease, including diagnostic findings from a duodenal biopsy AND have had this diagnosis at least 12 months prior to Screening 6. Adhered to a gluten-free diet and willing to comply with a gluten-free diet 7. 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 months 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 | 20/10/2025 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- Australia
- Netherlands
- New Zealand
Study participating centres
3025
Australia
4068
Australia
1010
New Zealand
5036
New Zealand
0622
New Zealand
5010
New Zealand
6815 AD
Netherlands
1081 HV
Netherlands
Sponsor information
Industry
10770 Wateridge Circle, Suite 21, CA
San Diego
92121
United States of America
| Phone | +1 (0)4042746330 |
|---|---|
| clinicaltrialinfo@anaptysbio.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 13/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | There is no plan to publish |
| IPD sharing plan | The researchers do not plan to share participant level data as the primary and secondary endpoints are safety and pharmacodynamic related and the celiac disease endpoints are exploratory in nature. All participant level data will be used for internal decision making for future development planning. |
Editorial Notes
10/07/2025: Study's existence confirmed by the Southern Health and Disability Ethics Committee.
