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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Nielsen Fernandez-Becker
Study ID
NCT07377565
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HB-2121 — DRUG
    HB-2121 taken once orally.

Study Details

The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults with suspected celiac disease. It will also look at how the drug affects the small intestine. The main questions it aims to answer are: * What side effects do participants have after receiving HB-2121? * How does the drug interact with the small intestine in people with suspected celiac disease? 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 four hours before their standard-of-care esophagogastroduodenoscopy * 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

Key Dates

Start date
Apr 1, 2026
Status verified
Jul 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 250 mg HB-2121 in Participants with Suspected Celiac Disease
    Participants in this arm will receive a one-time dose of 250 mg of HB-2121.

Primary Outcome Measure

Frequency and severity of adverse events during the study window [ Time Frame: From dosing through 30 days post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Medicine Clinical and Translational Research Unit (CTRU)Palo AltoCalifornia94304
CTRU Director
[email protected]
(650) 497-8168

Find similar trials in Palo Alto, CA

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
Stanford Medicine Clinical and Translational Research Unit (CTRU)· Palo Alto, CA

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