Trials / Not Yet Recruiting
Not Yet RecruitingNCT07178613
Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- The First Affiliated Hospital of Xinxiang Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Serine（Oral） | This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine. |
| DRUG | Fluoropyrimidine Drugs | This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine. |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2026-02-01
- Completion
- 2026-02-01
- First posted
- 2025-09-17
- Last updated
- 2025-09-17
Source: ClinicalTrials.gov record NCT07178613. Inclusion in this directory is not an endorsement.