Trials / Completed
CompletedNCT06356389
A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of JX11502MA Capsules in Patients With Schizophrenia.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Zhejiang Jingxin Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia
Detailed description
This study adopts a multi-center, randomized, double-blind, dose-increasing, parallel-control titration drug delivery study design. Preset three dose groups (S1, S2, S3), low, medium and high, with target doses of 1.5mg, 3mg and 6mg respectively. Each dose group included 20 subjects (16 patients received the test drug and 4 patients received placebo). During the test, observe the safety and tolerance of the subjects, and collect PK blood samples. Schizophrenic patients who met the inclusion criteria after screening and evaluation were randomly enrolled on the baseline day. On the first administration day, all dose groups took 1.5mg as the starting dose. Each subject should closely observe the tolerance and safety within 24 hours after the first administration. Only when the investigator evaluated it as tolerable, can the subsequent multiple administration be continued.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JX11502MA | Oral capsule |
| DRUG | Placebo | Oral capsule |
Timeline
- Start date
- 2022-03-02
- Primary completion
- 2022-12-27
- Completion
- 2023-01-28
- First posted
- 2024-04-10
- Last updated
- 2024-04-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06356389. Inclusion in this directory is not an endorsement.