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
Celiac disease
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.
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
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.