Advanced Solid Tumors
Conditions
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.
Interventions
DRUGDN1406131
IDO1 and TDO2 inhibitor
DRUGPlacebo
Placebo
Sponsors
Shanghai De Novo Pharmatech Co., Ltd.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events - type, incidence, severity | 28 day | Evaluate the safety and toxicity of DN1406131 in healthy volunteers |
| Maximum Tolerated Dose | 14 day | To define the Maximum Tolerated Dose (MTD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 48 hours | Cmax |
| Serum for biomarkers of IDO activity (kynurenine and tryptophan) | 48 hours | Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy. Pharmacodynamics（PD） |
| Elimination half-life | 48 hours | T1/2 |
| peak time | 48 hours | Tmax |
Countries
China
Contacts
Primary ContactWanwan Ji
Backup ContactShunpeng Hu
Outcome results
None listed