A Clinical Study of SPH9788 Tablets in Healthy Chinese Su... | NCT06839131

Studies
A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

NCT06839131

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Status

Recruiting

Last Update Posted

May 5, 2026Actual

Enrollment

94Estimated

Phase

Phase 1

Conditions

Healthy Participants

Interventions

SPH9788
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 18, 2025

First Submission Date that Met QC Criteria

Feb 18, 2025

First Posted Date

Feb 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 5, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Estimated

Label	Type	Description	Intervention Names
SPH9788	Experimental		Drug: SPH9788
Placebo Comparator	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SPH9788	Drug	SPH9788 tablets administered orally	SPH9788
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
(一) 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 1 year

Secondary Outcomes

Measure	Description	Time Frame
PK(Pharmacokinetics):Tmax	Time to peak plasma concentration (Tmax)	Approximately 1 year
PK(Pharmacokinetics):Cmax	Maximum serum concentration(Cmax)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects aged from 18 to 45 years;
Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;;
Subjects who voluntarily participate and sign informed consent form;
Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.

Exclusion Criteria:

Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
Substance abuse history within 1 year prior to screening or positive urine drug screen;
Alcohol abuse history within 1 year or positive alcohol breath test;
Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
Pregnant or lactating women;
Positive pregnancy test before study drug administration, or male and female subjects who refuse to use effective contraceptive methods during and for 6 months post-trial, or who have plans to donate sperm or eggs;
Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided