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Recruiting

NCT Number: NCT06483373

A Clinical Study of SPH7854 Granules in Healthy Subjects.

To evaluate the safety of SPH7854 in healthy subjects.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

West China Second University Hospital, Sichuan University

Chengdu, China

Location status: Recruiting

Location contact

Qin Yu

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Other circumstances that meet the protocol exclusion criteria.

Treatment and study plan

SPH7854

Drug

SPH7854: Orally, 50-3200mg

Placebo

Drug

Placebo:Orally;

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Approximately 2 years

    Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcomes

  1. PK(Pharmacokinetics):Tmax

    Time frame: Approximately 2 years

    Time to peak plasma concentration (Tmax)

  2. PK(Pharmacokinetics):Cmax

    Time frame: Approximately 2 years

    Maximum serum concentration(Cmax)

  3. PK(Pharmacokinetics):AUC

    Time frame: Approximately 2 years

    Area under the plasma concentration versus time curve (AUC)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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