- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641794
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
July 31, 2019 updated by: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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
Conditions
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
- Name: Wanwan Ji
- Phone Number: 18852605644
- Email: jiwanwan@sh-qingfeng.net
Study Contact Backup
- Name: Shunpeng Hu
- Phone Number: +86 13683002413
- Email: hushunpeng@sh-qingfeng.net
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.
Collaborators
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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