Actively Recruiting
A Single and Multiple Dose-escalation, and Food Effects Study to Evaluate the Safety and Pharmacokinetics of SPH7854 Granules in Healthy Adults
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-05-05
111
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of SPH7854 in healthy adults aged 18 to 45 years. This early phase 1 clinical trial aims to understand how well SPH7854 is tolerated and its effects on the body, focusing on inflammatory bowel disease. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and includes a randomized, double-blind design to compare SPH7854 with a placebo. Participants will receive SPH7854 granules orally at doses ranging from 50 to 3200 mg or a placebo. The study involves single and multiple dose escalations as well as an assessment of how food affects the drug. Both the experimental drug and placebo are given by mouth, and the trial includes several treatment groups to evaluate different dosing levels and conditions. During the approximately two-year study period, researchers will monitor participants for treatment-emergent adverse events and serious adverse events to assess safety. They will also measure pharmacokinetic parameters such as Tmax, Cmax, and AUC to understand how the drug is absorbed and processed in the body. Healthy volunteers will undergo medical exams and provide informed consent, with close monitoring throughout the trial to ensure safety and adherence.
CONDITIONS
Brief Title
A Clinical Study of SPH7854 Granules in Healthy Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate in clinical research and sign informed consent
- Healthy volunteers
- Examination results normal or clinically insignificant before dosing
- No fertility, sperm donation, or egg donation plans and willing to use effective contraception during the study period
You will not qualify if you...
- Female subjects who are breastfeeding or have a positive pregnancy test
- History of chronic, unstable, or recurrent diseases or surgeries deemed ineligible by investigator
- History of severe allergies or allergic diseases
- Use of prohibited drugs or foods before first dose
- Evidence of infection preventing enrollment
- Other protocol-defined exclusion conditions as judged by the investigator or protocol criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive SPH7854 or placebo orally in single and multiple dose-escalation phases to evaluate safety and pharmacokinetics.
Multiple visits for dosing and assessments as per study protocol
Duration - Up to approximately 2 years
Participants are monitored for treatment-emergent adverse events and pharmacokinetic outcomes after dosing ends.
Periodic visits for safety and pharmacokinetic monitoring
Trial Site Locations
Total: 1 location
1
West China Second University Hospital, Sichuan University
Chengdu, China
Actively Recruiting
Research Team
Q
Qin Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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