Trials / Unknown
UnknownNCT03453034
Tolerance and Pharmacokinetics of TQ-B3233
To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
Detailed description
The maximum tolerated dose (MTD) of TQ-B3233 \[ Time Frame: 48 weeks \] \[ Designated as safety issue: Yes \]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment. Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQ-B3233 | QD or BID in different stage of this research |
Timeline
- Start date
- 2017-11-22
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
- First posted
- 2018-03-05
- Last updated
- 2018-03-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03453034. Inclusion in this directory is not an endorsement.