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.
1 other identifier
interventional
111
1 country
1
Brief Summary
To evaluate the safety of SPH7854 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2024
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2024
CompletedFirst Submitted
Initial submission to the registry
June 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 5, 2026
April 1, 2026
2.6 years
June 24, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Approximately 2 years
Secondary Outcomes (3)
PK(Pharmacokinetics):Tmax
Approximately 2 years
PK(Pharmacokinetics):Cmax
Approximately 2 years
PK(Pharmacokinetics):AUC
Approximately 2 years
Study Arms (2)
SPH7854
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- Female subjects who are breastfeeding or have positive pregnancy results;
- Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
- Subjects suffering from allergic diseases or having a history of severe allergies;
- Subjects who took the drug or food prohibited by the protocol prior to the first dose;
- Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Second University Hospital, Sichuan University
Chengdu, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2024
First Posted
July 3, 2024
Study Start
May 28, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04