Clinical trial · Interventional
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
A Phase I Study of DN1406131 in Healthy Adults
NCT03641794CI-TRIAL-00039844unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DN1406131 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DN1406131
- description
- 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
- interventionNames
- Drug: DN1406131
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- adverse events - type, incidence, severity
- timeFrame
- 28 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater of 18 years and less than 45 * Weight ≥50 kg,body mass index of 19\~26 kg/m2 * Signed ICF Exclusion Criteria: * active autoimmune disease * uncontrolled concurrent illness * Smoking * Drugs * positive serology for HIV, Hepatitis B or C,Syphilis * Pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.