A Clinical Trial of TQH3906 Capsules in Healthy Volunteers
- Conditions
- Psoriasis
- Interventions
- Drug: TQH3906 capsuleDrug: TQH3906 placebo
- Registration Number
- NCT06230588
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Brief Summary
This study was divided into three parts: single and multiple dosing and food effect study, which were designed to evaluate the safety and tolerability of TQH3906 capsules administered in single or multiple dose escalation in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
- Healthy subjects aged 18-55 years (including 18 and 55 years), regardless of gender.
- Males weighing ≥ 50 kg, females weighing ≥ 45 kg, with a body mass index (BMI) of 19-26 kg/m2 (included).
- Be in good health with no abnormalities of clinical significance according to medical history, clinical symptoms, vital signs, physical examination, 12-lead electrocardiogram, chest radiographs, abdominal ultrasound, and laboratory tests
- Have a full understanding of the study, participate in the trial voluntarily, and have signed a written informed consent form.
- Subjects (including partners) are willing to voluntarily use appropriate and effective contraception from screening until 3 months after the last dose of study drug.
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Pregnant, lactating women.
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Previous history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, infectious, hematologic, neurologic, or psychiatric disorders/abnormalities, or related chronic illnesses, or acute illnesses, which the investigator assesses as contraindicated for participation in the trial.
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Have a QTc > 450 ms in males and > 470 ms in females at screening, or whose Electrocardiograph (ECG) is unsuitable for Concentration QT (C-QT) measurement (at the discretion of the investigator).
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The presence of risk factors and history of tip-twist ventricular tachycardia including, but not limited to: unexplained syncope, long QT syndrome, heart failure, or clinically significant abnormal laboratory tests (including hypokalemia, hypercalcemia, or hypomagnesemia) identified at Screening.
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Presence of abnormal serum virology at screening;
- Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or Hepatitis C virus (HCV) antibody positive;
- Positive for Human immunodeficiency virus (HIV) antibody at the screening stage, or previous history of HIV infection;
- Positive antibodies to Treponema pallidum in screening.
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Presence of active tuberculosis during the Screening Period, or being a close household contact of a patient with untreated active tuberculosis, or having a positive tuberculosis interferon gamma release assay (TB-IGRA) by laboratory examination.
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A history of severe bacterial, fungal or viral infection requiring hospitalization for intravenous antibiotic or antiviral medication within 2 months prior to randomization.
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Live vaccination within 4 weeks prior to randomization or planning to receive a live vaccine during the study.
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The presence of clinically significant infections during the Screening Period, including but not limited to upper respiratory tract infections, lower respiratory tract infections, herpes simplex, herpes zoster, and requiring treatment with antibiotics or antiviral medications.
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A history of severe herpes zoster or herpes simplex infection including, but not limited to, herpes encephalitis, disseminated herpes simplex, and herpes zoster pandemic.
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Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 months prior to randomization, or use of any topical cytotoxic or topical immunosuppressive drug within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
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Receipt of a biologic or other clinical trial drug within 3 months or 5 half-lives, whichever is longer, prior to randomization.
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Has undergone surgery within 4 weeks prior to randomization or is scheduled to undergo surgery during the study.
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Who has lost or donated more than 400 mL of blood within 4 weeks prior to randomization.
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Who have taken any prescription, over-the-counter, and herbal medications, except vitamin products, within 4 weeks prior to randomization.
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Persons with potential blood collection difficulties and a history of needle and blood sickness.
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Allergy to any of the known components of TQH3906 or any previous history of severe drug allergy.
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History of substance abuse or positive urine drug screen.
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Who have smoked more than 5 cigarettes/day or used an equivalent amount of nicotine or nicotine-containing products in the 3 months prior to randomization, or who are unable to discontinue the use of any tobacco-based products during the trial.
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Those who have chronic alcohol abuse or who have consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits of 40% alcohol by volume or 150 mL of wine) in the 3 months prior to screening or who are unable to abstain from alcohol for the duration of the trial, or who have a positive breath test for alcohol.
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Have any other valid medical, psychiatric, or social reason that, in the opinion of the investigator, precludes participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQH3906 capsule TQH3906 capsule TQH3906 capsule for oral administration as a single or multiple dose for 7days. TQH3906 placebo capsule TQH3906 placebo TQH3906 placebo capsule for oral administration as single dose or multiple dose for 7days.
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events (TEAEs) Up to 18 days Incidence of treatment-emergent adverse events (TEAEs)
Adverse events (AE) Up to 18 days Incidence of adverse events (AE)
Serious Adverse Events (SAE) Up to 18 days Incidence of serious adverse events (SAE)
- Secondary Outcome Measures
Name Time Method Plasma elimination half-life (t1/2) Up to 18 days The time required for the concentration of a drug in the blood or the amount of drug in the body to be reduced to 1/2. The time required for absorption, distribution and elimination of half the amount of drug (or blood concentration) in the body becomes the absorption half-life, distribution half-life and elimination half-life, respectively.
Time to peak concentration (Tmax) Up to 18 days The time it takes to reach the peak concentration
Steady state peak concentration (Cmax, ss) Up to 18 days The steady-state blood drug concentration is a serrated plasma drug concentration curve, with the highest steady-state blood drug concentration being the peak steady-state blood drug concentration.
Steady state valley concentration (Cmin, ss) Up to 18 days The steady-state blood drug concentration is a serrated plasma drug concentration curve, with the lowest steady-state blood drug concentration being the trough of the steady-state blood drug concentration.
Area under steady-state blood drug concentration time curve (AUC0- τ) Up to 18 days After a single dose administration, the amount of medication absorbed into the human bloodstream can be estimated using the area under the blood drug concentration time curve, with the unit of Auc being concentration \* time.
Peak concentration (Cmax) Up to 18 days Maximum plasma drug concentration
Area under the blood concentration-time curve Up to 18 days The amount of drug absorbed into the circulation after administration of a single dose can be estimated from the area under the blood concentration-time curve, with Auc in units of concentration \* time.
Apparent volume of distribution (Vd/F) Up to 18 days It is the ratio of the amount of drug in the body to the blood concentration of the drug when the drug reaches dynamic equilibrium in the body is called the apparent volume of distribution.
Steady-state peaking time (Tmax, ss) Up to 18 days The time required to reach a steady-state peak concentration after administration.
Plasma clearance (CL/F) Up to 18 days It is the sum of drug clearance by the liver and kidneys, etc., i.e., how many volumes of plasma are cleared of drug per unit of time in L/h, or L/(kg-h) if calculated on the basis of body weight.
Average steady-state blood drug concentration (Cav, ss) Up to 18 days The average concentration reached when the drug concentration reaches a steady state after a continuous given dose of medication.
Accumulation ratio (Rac) Up to 18 days The ratio of the required dose for a single administration to the total dose required for a split administration.
Renal clearance rate (CLr/F) Up to 18 days The ability of both kidneys to completely remove a substance equivalent to several milliliters of plasma within one minute.
QTcF interval Up to 18 days Effect of TQH3906 on the QTcF interval in healthy subjects.
INF-γ release Up to 18 days Inhibition efficiency of INF-γ release by TQH3906 in IL-12/IL-18-stimulated peripheral blood mononuclear cells from subjects.
Trial Locations
- Locations (1)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China