A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic of TQB3702 Tablets in Healthy Adult Subjects

NCT06448273 | Recruiting Phase 1

• 1 other identifier: TQB3702-I-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, randomized, double-blind, placebo-controlled, dose-escalating clinical study aimed at evaluating the safety of TQB3702 tablets following single and multiple doses administered to healthy subjects

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Adverse events rate

  Number of subjects with adverse events (AEs) and serious adverse events (SAEs), the evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0).

  17 days

• Abnormal laboratory test indicators

  Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

  17 days

Secondary Outcomes (3)

• Time to reach maximum observed plasma concentration (Tmax)

  1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose

• Maximum Plasma Concentration (Cmax)

  1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose

• Elimination half-life (t1/2)

  1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose

Study Arms (2)

TQB3702 tablets

EXPERIMENTAL

TQB3702 tables is administered as a single dose or multiple dose.

Drug: TQB3702 tablets

TQB3702 placebo

PLACEBO COMPARATOR

TQB3702 placebo is administered as a single dose or multiple dose.

Drug: TQB3702 placebo

Interventions

TQB3702 tablets DRUG

TQB3702 tablets is administered as a single dose on day 1, or once daily on Days 1 to 7 on multiple dose. Dosage: 100mg, 150/200mg.

TQB3702 tablets

TQB3702 placebo DRUG

TQB3702 placebo contains no active substance.

TQB3702 placebo

Eligibility Criteria

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

You may qualify if:

• Healthy participants are aged between 18 and 55 years old (including 18 and 55 years old), regardless of gender;
• Male weight ≥50kg, female weight ≥45kg, with a body mass index (BMI) between 19 and 26 kg/m2;
• Fully understand this study, voluntarily participate in the trial, and have signed a written informed consent form;
• Subjects (including partners) are willing to self screen and voluntarily take appropriate and effective contraceptive measures (non contraceptive pills) within 6 months after the last study drug administration.

You may not qualify if:

• Pregnant and lactating women.
• Previous or current history of heart, endocrine, metabolic, kidney, liver, gastrointestinal, skin, infection, blood, neurological, or psychiatric diseases/abnormalities, or related chronic or acute diseases, the researcher assessed that it is not suitable to participate in the trial.
• Screening period vital signs, physical examination, laboratory examination, 15 lead electrocardiogram, chest anteroposterior lateral X-ray, abdominal ultrasound, female subjects also need to undergo uterine and bilateral accessory ultrasound, with abnormal and clinically significant results.
• There are serum virological abnormalities during the screening period;
• Active tuberculosis exists in the screening period, or is a close family contact of untreated active tuberculosis patients, or laboratory test T-SPOT.TB (a type of Enzyme-Linked Immunospot Assay) test positive individuals.
• Suffering from a history of severe bacterial, fungal, or viral infections within the first two months of randomization, requiring hospitalization and treatment with intravenous antibiotics or antiviral drugs.
• Randomly receive live vaccine within the first 4 weeks or plan to receive live vaccine during the study period.
• During the screening period, clinically significant infections may occur, including but not limited to upper respiratory tract infections, lower respiratory tract infections, urinary tract infections, etc., and require antibiotic or antiviral treatment.
• A history of severe herpes zoster or herpes simplex infection, including but not limited to herpes simplex encephalitis, disseminated herpes simplex, and generalized herpes zoster.
• Use any systemic cytotoxicity or systemic immunosuppressive drugs within the first 6 months of randomization or during the study period, or use any local cytotoxicity or local immunosuppressive drugs within the first 4 weeks of randomization or 5 half-lives or during the study period.
• Any other biological agents that have been marketed or studied within the first three months or five half-lives of randomization.
• Individuals who have undergone surgery within the first 4 weeks of randomization or plan to undergo surgery during the study period.
• Individuals who have lost blood or donated more than 400 mL of blood within the first 4 weeks of randomization.
• Individuals who have experienced external injuries within the first 6 months of randomization, such as car accidents, fractures, etc.
• Within the first 4 weeks of randomization, any prescription, over-the-counter, or herbal medication was taken, except for vitamin products.

Sponsors & Collaborators

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

Study Sites (1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, 519041, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Shilong Zhong, Doctor

CONTACT

18620829696; gdph_zhongsl@gd.gov.cn

Study Design

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

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: July 19, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-04

Locations

CN (1)