A Clinical Study of SPH7854 Granules in Healthy Subjects.
Early Phase 1 · Testing SPH7854 · 1 site · Shanghai Pharmaceuticals Holding Co., Ltd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing SPH7854 (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 45
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
- Healthy volunteers;
- Before receiving the investigational drug, the examination results were normal or clinically insignificant;
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 111 participants are expected to take part.
- Start date: 2024-05-28.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Approximately 2 years)
In the researchers’ words
To evaluate the safety of SPH7854 in healthy subjects.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
| Enrollment | 111 (estimated) |
| Start date | 2024-05-28 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2024-07-03 |
| Last updated | 2026-05-05 |
| Official title | A Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability/Safety/Pharmacokinetics of SPH7854 Granules in Healthy Subjects. |
| ClinicalTrials.gov ID | NCT06483373 |
Interventions
- SPH7854 (Drug)
SPH7854： Orally, 50-3200mg - Placebo (Drug)
Placebo：Orally；
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent； 2. Healthy volunteers; 3. Before receiving the investigational drug, the examination results were normal or clinically insignificant; 4. Subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing. Exclusion Criteria: 1. Female subjects who are breastfeeding or have positive pregnancy results; 2. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent; 3. Subjects suffering from allergic diseases or having a history of severe allergies; 4. Subjects who took the drug or food prohibited by the protocol prior to the first dose; 5. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement; 6. Other circumstances that meet the protocol exclusion criteria.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| West China Second University Hospital, Sichuan University | Chengdu | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.