A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2072 Tablets

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorInnovStone Therapeutics Limited

About this trial

This is a first-in-human study to evaluate the safety, tolerability, PK, and PD characteristics of SYH2072 Tablets after single and multiple oral doses in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must be fully informed about the study content, procedures, and potential adverse reactions, and voluntarily sign the written informed consent form (ICF) before the study;

Sex: Male or female;

Age: 18-55 years old (inclusive);

Body mass index in the range of 19 to 30 kg•m-2 [Body Mass Index (BMI) = weight/height2 (kg•m²)] (inclusive), with a body weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);

Disqualifiers

History of severe allergic diseases or allergic constitution (allergy to ≥ 3 drugs or foods);

Use of corticosteroid drugs within 3 months prior to screening;

Past and/or current clinically significant medical conditions, including but not limited to diseases of the circulatory, hematologic or hematopoietic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, tumors, severe trauma, or any other disease that the investigator considers should be excluded or may interfere with the interpretation of the study results;

Postural tachycardia (heart rate increase > 30 beats/minute upon standing) or postural hypotension (decrease in SBP ≥ 20mmHg or DBP ≥ 10mmHg upon standing) at screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYH2072 Tablets

    Drug

    SYH2072 tablets will be administered as a single or multiple oral doses.

  • SYH2072 Placebo

    Drug

    SYH2072 placebo tablets will be administered as a single or multiple oral doses.

Treatment groups

112 Participants
are divided into 3 treatment groups
Group A: Single Ascending Doses (SAD, Part A)Experimental treatment 2 interventions
Group B: Food Effect (FE, Part B)Experimental treatment 1 intervention
Group C: Experimental: Multiple Ascending Doses (MAD, Part C)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The rate of Adverse events

The rate of Adverse events occur during the whole study

Time frame
Through study completion, an average of 8 months
2

The rate of normality or abnormality of electrocardiogram

The rate of normality or abnormality of electrocardiogram during the whole study

Time frame
Through study completion, an average of 8 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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