A Clinical Trial of TQH3906 Capsules in Healthy Volunteers

Last updated: March 1, 2024
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Skin Wounds

Rosacea

Warts

Treatment

TQH3906 placebo

TQH3906 capsule

Clinical Study ID

NCT06230588
TQH3906-I-01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 medicalhistory, clinical symptoms, vital signs, physical examination, 12-leadelectrocardiogram, chest radiographs, abdominal ultrasound, and laboratory tests
  • Have a full understanding of the study, participate in the trial voluntarily, and havesigned a written informed consent form.
  • Subjects (including partners) are willing to voluntarily use appropriate and effectivecontraception from screening until 3 months after the last dose of study drug.

Exclusion

Exclusion Criteria:

  • Pregnant, lactating women.
  • Previous history or current cardiac, endocrine, metabolic, renal, hepatic,gastrointestinal, dermatologic, infectious, hematologic, neurologic, or psychiatricdisorders/abnormalities, or related chronic illnesses, or acute illnesses, which theinvestigator assesses as contraindicated for participation in the trial.
  • Have a QTc > 450 ms in males and > 470 ms in females at screening, or whoseElectrocardiograph (ECG) is unsuitable for Concentration QT (C-QT) measurement (at thediscretion of the investigator).
  • The presence of risk factors and history of tip-twist ventricular tachycardiaincluding, 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.
  • Presence of abnormal serum virology at screening;
  1. Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or Hepatitis Cvirus (HCV) antibody positive;
  2. Positive for Human immunodeficiency virus (HIV) antibody at the screening stage,or previous history of HIV infection;
  3. Positive antibodies to Treponema pallidum in screening.
  • Presence of active tuberculosis during the Screening Period, or being a closehousehold contact of a patient with untreated active tuberculosis, or having apositive tuberculosis interferon gamma release assay (TB-IGRA) by laboratoryexamination.
  • A history of severe bacterial, fungal or viral infection requiring hospitalization forintravenous antibiotic or antiviral medication within 2 months prior to randomization.
  • Live vaccination within 4 weeks prior to randomization or planning to receive a livevaccine during the study.
  • The presence of clinically significant infections during the Screening Period,including but not limited to upper respiratory tract infections, lower respiratorytract infections, herpes simplex, herpes zoster, and requiring treatment withantibiotics or antiviral medications.
  • A history of severe herpes zoster or herpes simplex infection including, but notlimited to, herpes encephalitis, disseminated herpes simplex, and herpes zosterpandemic.
  • Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 months priorto randomization, or use of any topical cytotoxic or topical immunosuppressive drugwithin 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
  • Receipt of a biologic or other clinical trial drug within 3 months or 5 half-lives,whichever is longer, prior to randomization.
  • Has undergone surgery within 4 weeks prior to randomization or is scheduled to undergosurgery during the study.
  • Who has lost or donated more than 400 mL of blood within 4 weeks prior torandomization.
  • Who have taken any prescription, over-the-counter, and herbal medications, exceptvitamin products, within 4 weeks prior to randomization.
  • Persons with potential blood collection difficulties and a history of needle and bloodsickness.
  • Allergy to any of the known components of TQH3906 or any previous history of severedrug allergy.
  • History of substance abuse or positive urine drug screen.
  • Who have smoked more than 5 cigarettes/day or used an equivalent amount of nicotine ornicotine-containing products in the 3 months prior to randomization, or who are unableto discontinue the use of any tobacco-based products during the trial.
  • Those who have chronic alcohol abuse or who have consumed more than 14 units ofalcohol per week (1 unit = 360 mL of beer or 45 mL of spirits of 40% alcohol by volumeor 150 mL of wine) in the 3 months prior to screening or who are unable to abstainfrom alcohol for the duration of the trial, or who have a positive breath test foralcohol.
  • Have any other valid medical, psychiatric, or social reason that, in the opinion ofthe investigator, precludes participation in this study.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: TQH3906 placebo
Phase: 1
Study Start date:
February 02, 2024
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 61000
    China

    Active - Recruiting

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