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

Official title

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2072 Tablets in Healthy Participants

Overview

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.

Interventions

• Drug SYH2072 Tablets
  SYH2072 tablets will be administered as a single or multiple oral doses.
• Drug SYH2072 Placebo
  SYH2072 placebo tablets will be administered as a single or multiple oral doses.

Primary outcome measures

• The rate of Adverse events [Time frame: Through study completion, an average of 8 months]
• The rate of normality or abnormality of electrocardiogram [Time frame: Through study completion, an average of 8 months]

Eligibility criteria

Inclusion criteria

• 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 \[Body Mass Index (BMI) = weight/height2 (kg•m\^2)\] (inclusive), with a body weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
• Participants are able to communicate well with the investigator and are able to complete the study in accordance with the protocol.

Exclusion criteria

• 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;
• Have undergone major surgery within 6 months prior to screening, or plan to undergo major surgery during the study;
• Potassium ion level outside the normal range in clinical chemistry tests at screening, or serum creatinine > upper limit of normal (ULN);
• Any one of the following at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) > 1.2×ULN (one re-test within 1 week is allowed);
• Estimated glomerular filtration rate (eGFR) < 90mL/min/1.73 m2 at screening;
• Prolonged QT/QTc interval at screening (QTcF ≥ 450ms for males, ≥ 470ms for females);
• Positive for any of the following: HBsAg, HCV antibody, syphilis antibody, or HIV antibody;
• Blood loss or blood donation exceeding 200mL within 3 months prior to screening (excluding menstruation for females), and/or platelet donation within 2 weeks;
• Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or dietary supplements (including vitamins, health products, etc.) within 28 days prior to screening;
• History of drug abuse, and/or use of illicit drugs within 3 months prior to screening, and/or habitual use of any psychotropic drugs, including Chinese herbal medicines, and/or a positive urine drug screen;
• Average daily smoking of more than 5 cigarettes (or an equivalent amount of tobacco in e-cigarettes) within 3 months prior to screening, and/or unwilling to avoid using any tobacco products during the study;
• Regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360mL of 5% alcohol beer or 45mL of 40% alcohol spirits or 150mL of 12% alcohol wine), and/or inability to abstain from alcohol intake during the study, and/or a positive breath alcohol test;
• Excessive daily consumption of tea, coffee, and/or caffeinated beverages (8 cups or more, 1 cup = 250mL) within 1 month prior to screening, and/or unwilling to abstain from tea, coffee, and/or caffeinated foods, grapefruit and/or grapefruit juice, and/or poppy-containing products during the study;
• Having a fertility plan (including sperm or egg donation) from the time of signing the ICF until 3 months after the last dose, and/or unwilling to use an effective non-drug method of contraception;
• Participation in any clinical study within 3 months prior to screening;
• Participants who may be unable to complete the study for other reasons or who are deemed unsuitable for inclusion by the investigator.

In addition to the above requirements, female participants who meet the following criteria will also be excluded:

• Pregnant or lactating women;
• Use of oral contraceptives within 28 days prior to screening;
• Use of long-acting estrogen and/or progestogen injections and/or implants within 6 months prior to screening; 23）Women of childbearing potential who have had unprotected sexual intercourse with a partner within 28 days prior to dosing.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Anzhen Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07647783 · SYH2072-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗