Trial | NCT03641794  Report issue

Title

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
A Phase I Study of DN1406131 in Healthy Adults

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    DN1406131 ...

  • Study Participants

    56
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.
Study Started
Sep 07
2018
Primary Completion
May 13
2019
Study Completion
Jul 31
2019
Anticipated
Last Update
Aug 01
2019

Drug DN1406131

IDO1 and TDO2 inhibitor

Drug Placebo

Placebo

DN1406131 Experimental

25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg

Placebo Placebo Comparator

25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg

Criteria 

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
No Results Posted