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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Study of DN1406131 in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641794
• Other study ID #: DN-DN1406131-101
• Status: Recruiting
• Phase: Phase 1
• Start date: September 7, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2018
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Wanwan Ji
• Phone: 18852605644
• Email: jiwanwan[@]sh-qingfeng.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: July 31, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• DN1406131
IDO1 and TDO2 inhibitor
• Placebo
Placebo

Locations

Country	Name	City	State
China	PKUCare Luzhong Hospital	Zibo	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.	Shanghai De Novo Pharmatech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events - type, incidence, severity	Evaluate the safety and toxicity of DN1406131 in healthy volunteers	28 day
Primary	Maximum Tolerated Dose	To define the Maximum Tolerated Dose (MTD)	14 day
Secondary	Peak Plasma Concentration (Cmax)	Cmax	48 hours
Secondary	Serum for biomarkers of IDO activity (kynurenine and tryptophan)	Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy.; Pharmacodynamics(PD)	48 hours
Secondary	Elimination half-life	T1/2	48 hours
Secondary	peak time	Tmax	48 hours