A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease

NCT07063823 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB-80209
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug. The main questions it aims to answer are:

• What side effects do participants have after receiving HB-2121?
• How much HB-2121 is in the blood over time? Researchers will follow participants for 30 days after receiving HB-2121 to understand how the drug behaves in the body and how safe it is. Participants will:
• Receive one oral dose of HB-2121
• Attend 4 in-person clinic visits for checkups, lab tests, and monitoring
• Complete 2 remote visits that include safety lab assessments
• Fill out a short daily questionnaire for 7 days about symptoms and health status

Conditions

Celiac Disease; Healthy

Keywords

Celiac Disease; HB-2121; Healthy Volunteers; Gluten Intolerance

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events during the study window

  Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  From dosing through 30 days post-dose

Secondary Outcomes (3)

• Peak Plasma Concentration (Cmax) of HB-2121

  Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.

• Time to Peak Plasma Concentration (Tmax) of HB-2121

  Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.

• Area Under the Plasma Concentration-Time Curve (AUC) for HB-2121

  Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.

Other Outcomes (1)

• Frequency and identity of HB-2121 positive cells in the blood of healthy subjects and patients with celiac disease

  60, 120, 180, 240, and 360 minutes, and 1 day after dosing

Study Arms (6)

50 mg HB-2121 in Healthy Volunteers

EXPERIMENTAL

Participants in this arm will receive a one-time dose of 50 mg of HB-2121.

Drug: HB-2121

150 mg HB-2121 in Healthy Volunteers

EXPERIMENTAL

Participants in this arm will receive a one-time dose of 150 mg of HB-2121.

Drug: HB-2121

250 mg HB-2121 in Healthy Volunteers

EXPERIMENTAL

Participants in this arm will receive a one-time dose of 250 mg of HB-2121.

Drug: HB-2121

50 mg HB-2121 in Participants with Celiac Disease

EXPERIMENTAL

Participants in this arm will receive a one-time dose of 50 mg of HB-2121.

Drug: HB-2121

150 mg HB-2121 in Participants with Celiac Disease

EXPERIMENTAL

Participants in this arm will receive a one-time dose of 150 mg of HB-2121.

Drug: HB-2121

250 mg HB-2121 in Participants with Celiac Disease

EXPERIMENTAL

Participants in this arm will receive a one-time dose of 250 mg of HB-2121.

Drug: HB-2121

Interventions

HB-2121 DRUG

HB-2121 taken once orally.

150 mg HB-2121 in Healthy Volunteers; 150 mg HB-2121 in Participants with Celiac Disease; 250 mg HB-2121 in Healthy Volunteers; 250 mg HB-2121 in Participants with Celiac Disease; 50 mg HB-2121 in Healthy Volunteers; 50 mg HB-2121 in Participants with Celiac Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older
• Body Mass Index (BMI) between 18 and 45 kg/m2
• Overall good health, as determined by medical history and a physical exam
• No use of an investigational drug in the past 12 weeks
• Able and willing to follow study procedures and provide written informed consent
• If of childbearing potential, participants must agree to use highly effective birth control during the study period. The same applies to male participants with partners of childbearing potential
• No diagnosis of celiac disease
• No first-degree relatives (parent, sibling, child) with celiac disease
• Able to eat gluten-containing foods without adverse effects
• No history of autoimmune gastrointestinal disorders such as Crohn's disease, ulcerative colitis, or eosinophilic enteritis
• Biopsy-confirmed diagnosis of celiac disease
• No history of eosinophilic enteritis, autoimmune gastrointestinal disorders such as Crohn's disease or inflammatory bowel disease

You may not qualify if:

• Pregnant, breastfeeding, or planning to become pregnant during the study period
• History of chemotherapy or pelvic radiation
• History of congenital long QT syndrome or prolonged QTcF interval
• Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease
• Current use of immunosuppressant medications
• Known allergy or sensitivity to any ingredients in the study drug
• Active cancer or history of cancer

Sponsors & Collaborators

• Stanford's Innovative Medicines Accelerator: collaborator
• Nielsen Fernandez-Becker: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Medicine - Gastroenterology & Hepatology

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 14, 2025
• Study Start: August 26, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-06

Locations

US (1)