Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DN1406131

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

Group Type EXPERIMENTAL

DN1406131

Intervention Type DRUG

IDO1 and TDO2 inhibitor

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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DN1406131

IDO1 and TDO2 inhibitor

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes