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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Lewis Gryziewicz
Public

AnaptysBio, Inc.
10770 Wateridge Circle, Suite 210, CA
San Diego
92121
United States of America

Phone +1 (0)4042746330
Email clinicaltrialinfo@anaptysbio.com
Dr Mark Rigby
Scientific

AnaptysBio, Inc.
10770 Wateridge Circle, Suite 210, CA
San Diego
92121
United States of America

Phone +1 (0)4042746330
Email clinicaltrialinfo@anaptysbio.com
Dr Nah Yeon (Tina) Baik
Principal Investigator

Level 2, 97 Grafton Road, Grafton
Grafton Auckland
1010
New Zealand

Phone (+649) 303-4987
Email tina@optimalclinicaltrials.com
Dr Oscar Walsh
Principal Investigator

Suite 9, 6/230 Blackshaws Road, VIC
Altona North
3025
Australia

Phone +61 (0)1300903512
Email owalsh@altonaclinicalresearch.com

Study information

Study designMulticenter double-blind randomized placebo-controlled parallel-arm trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther, Safety
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleA 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 objectivesPart 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) studiedCeliac disease
InterventionPart 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 typeDrug
Pharmaceutical study type(s)Pharmacokinetic, Pharmacodynamic
PhasePhase I
Drug / device / biological / vaccine name(s)ANB033
Primary outcome measureThe 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 measures1. 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 date30/10/2024
Completion date01/07/2026

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment20/10/2025
Date of final enrolment28/02/2026

Locations

Countries of recruitment

  • Australia
  • Netherlands
  • New Zealand

Study participating centres

Site 1
Altona North
3025
Australia
Site 2
Taringa
4068
Australia
Site 3
Auckland
1010
New Zealand
Site 4
Waikanae Beach
5036
New Zealand
Site 5
Auckland
0622
New Zealand
Site 6
Wellington
5010
New Zealand
Site 7
Arnhem
6815 AD
Netherlands
Site 8
Amsterdam
1081 HV
Netherlands

Sponsor information

AnaptysBio, Inc.
Industry

10770 Wateridge Circle, Suite 21, CA
San Diego
92121
United States of America

Phone +1 (0)4042746330
Email clinicaltrialinfo@anaptysbio.com

Funders

Funder type

Industry

AnaptysBio, Inc.

No information available

Results and Publications

Intention to publish date13/01/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThere is no plan to publish
IPD sharing planThe 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.