A Clinical Trial of TQH3906 Capsules in Healthy Volunteers

NCT06230588 | Completed Phase 1

• 1 other identifier: TQH3906-I-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Adverse events (AE)

  Incidence of adverse events (AE)

  Up to 18 days

• Serious Adverse Events (SAE)

  Incidence of serious adverse events (SAE)

  Up to 18 days

• Treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events (TEAEs)

  Up to 18 days

Secondary Outcomes (15)

• Time to peak concentration (Tmax)

  Up to 18 days

• Peak concentration (Cmax)

  Up to 18 days

• Area under the blood concentration-time curve

  Up to 18 days

• Apparent volume of distribution (Vd/F)

  Up to 18 days

• Plasma clearance (CL/F)

  Up to 18 days

Study Arms (2)

TQH3906 capsule

EXPERIMENTAL

TQH3906 capsule for oral administration as a single or multiple dose for 7days.

Drug: TQH3906 capsule

TQH3906 placebo capsule

PLACEBO COMPARATOR

TQH3906 placebo capsule for oral administration as single dose or multiple dose for 7days.

Drug: TQH3906 placebo

Interventions

TQH3906 capsule DRUG

TQH3906 is a kinase inhibitor.

TQH3906 capsule

TQH3906 placebo DRUG

Placebo Comparator

TQH3906 placebo capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant, lactating women.
• 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.
• 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).
• 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.
• 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.
• 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.
• A history of severe bacterial, fungal or viral infection requiring hospitalization for intravenous antibiotic or antiviral medication within 2 months prior to randomization.
• Live vaccination within 4 weeks prior to randomization or planning to receive a live vaccine during the study.
• 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.
• A history of severe herpes zoster or herpes simplex infection including, but not limited to, herpes encephalitis, disseminated herpes simplex, and herpes zoster pandemic.
• 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.
• Receipt of a biologic or other clinical trial drug within 3 months or 5 half-lives, whichever is longer, prior to randomization.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 61000, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: February 2, 2024
• Primary Completion: April 27, 2025
• Study Completion: April 27, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-04

Locations

CN (1)