A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.

ConditionHealhty
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the written informed consent form prior to the start of the study;

Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female;

Body weight ≥50 kg for male subjects and ≥45 kg for female subjects at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m² (inclusive);

Subjects (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use reliable contraceptive measures during this period.

Disqualifiers

Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study drug,

Physical examination, vital signs, laboratory tests,abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be clinically significant abnormalities;

Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion;

abnormal HbA1c at screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK55879

    Drug

    Dose 1 to dose 5

  • Placebo

    Drug

    dose 1 to dose 5

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: HSK55879Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The number and severity of treatment emergent adverse events (TEAEs)

To assess the safety and tolerability of HSK55879 in healthy adult volunteers

Time frame
15 days after single dose

Secondary outcomes

Other outcomes

Sponsors and contacts

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