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

A Phase I Study of DN1406131 in Healthy Adults

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 Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shandong
      • Zibo, Shandong, China, 255000
        • Recruiting
        • PKUCare Luzhong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DN1406131
25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
IDO1 and TDO2 inhibitor
PLACEBO_COMPARATOR: Placebo
25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events - type, incidence, severity
Time Frame: 28 day
Evaluate the safety and toxicity of DN1406131 in healthy volunteers
28 day
Maximum Tolerated Dose
Time Frame: 14 day
To define the Maximum Tolerated Dose (MTD)
14 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 48 hours
Cmax
48 hours
Serum for biomarkers of IDO activity (kynurenine and tryptophan)
Time Frame: 48 hours

Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy.

Pharmacodynamics(PD)

48 hours
Elimination half-life
Time Frame: 48 hours
T1/2
48 hours
peak time
Time Frame: 48 hours
Tmax
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Qinghong Zhou, Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 7, 2018

Primary Completion (ACTUAL)

May 13, 2019

Study Completion (ANTICIPATED)

July 31, 2019

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • DN-DN1406131-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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