NCT03641794

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 7, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 1, 2019

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

August 15, 2018

Last Update Submit

July 31, 2019

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • adverse events - type, incidence, severity

    Evaluate the safety and toxicity of DN1406131 in healthy volunteers

    28 day

  • Maximum Tolerated Dose

    To define the Maximum Tolerated Dose (MTD)

    14 day

Secondary Outcomes (4)

  • Peak Plasma Concentration (Cmax)

    48 hours

  • Serum for biomarkers of IDO activity (kynurenine and tryptophan)

    48 hours

  • Elimination half-life

    48 hours

  • peak time

    48 hours

Study Arms (2)

DN1406131

EXPERIMENTAL

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

Drug: DN1406131

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DN1406131DRUG

IDO1 and TDO2 inhibitor

DN1406131
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age greater of 18 years and less than 45
  • Weight ≥50 kg,body mass index of 19\~26 kg/m2
  • Signed ICF

You may not qualify if:

  • active autoimmune disease
  • uncontrolled concurrent illness
  • Smoking
  • Drugs
  • positive serology for HIV, Hepatitis B or C,Syphilis
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, 255000, China

RECRUITING

Study Officials

  • Qinghong Zhou

    Jiangxi Qingfeng Pharmaceutical Co. Ltd.

    STUDY DIRECTOR

Central Study Contacts

Wanwan Ji

CONTACT

18852605644jiwanwan@sh-qingfeng.net

Shunpeng Hu

CONTACT

+86 13683002413hushunpeng@sh-qingfeng.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 22, 2018

Study Start

September 7, 2018

Primary Completion

May 13, 2019

Study Completion

July 31, 2019

Last Updated

August 1, 2019

Record last verified: 2018-08

Locations

CN(1)