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

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Placebo; Drug: DN1406131

Study type: Interventional

Funder types: Industry

Identifiers

NCT03641794

DN-DN1406131-101

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

DN1406131

Experimental group

Description:

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

Treatment:

Drug: DN1406131

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo