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Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants

NCT06206811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-02-21

No results posted yet for this study

Summary

First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, and pharmacodynamics (PD) of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating inflammatory bowel disease (IBD) (including Crohn's disease and ulcerative colitis), Blau syndrome, and spondyloarthritis

Conditions

  • Inflammatory Bowel Diseases
  • Blau Syndrome
  • Crohn Disease
  • Ulcerative Colitis
  • Spondyloarthritis

Interventions

DRUG

OD-07656

innate immune modulator

Sponsors & Collaborators

  • Odyssey Therapeutics

    lead INDUSTRY

Principal Investigators

  • Anthony Opipari, MD, PhD · Odyssey Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2024-11-25
Completion
2024-11-25

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206811 on ClinicalTrials.gov