A Clinical Study of SPH7854 Granules in Healthy Subjects.

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.

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06483373

Enrollment

111

Registered

2024-07-03

Start date

2024-05-28

Completion date

2026-12-31

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Brief summary

To evaluate the safety of SPH7854 in healthy subjects.

Interventions

DRUGSPH7854

SPH7854： Orally, 50-3200mg

DRUGPlacebo

Placebo：Orally；

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Approximately 2 years	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary

Measure	Time frame	Description
PK(Pharmacokinetics):Tmax	Approximately 2 years	Time to peak plasma concentration (Tmax)
PK(Pharmacokinetics):Cmax	Approximately 2 years	Maximum serum concentration(Cmax)
PK(Pharmacokinetics):AUC	Approximately 2 years	Area under the plasma concentration versus time curve (AUC)

Countries

China

Contacts

CONTACTQin Yu

hxeyyb@126.com0086-028-85501685

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026