A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects

NCT07327281 | Recruiting Phase 1

• 1 other identifier: TQF3250-Ia-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (8)

• Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)

  Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs).

  Up to 20 days

• Number of participants with abnormal clinical laboratory test indicators

  Number of participants with abnormal clinical laboratory test indicators.

  Up to 20 days

• Changes in body temperature after using TQF3250 capsules

  Evaluate changes in body temperature after using TQF3250 capsules

  Up to 24 hour

• Tolerance assessment: 12-lead electrocardiogram

  Tolerance assessment: 12-lead electrocardiogram

  Up to 20 days

• Changes in pulse/heart rate after use of TQF3250 capsules

  Changes in pulse/heart rate after use of TQF3250 capsules

  Up to 24 hour

• Changes in respiratory rate after using TQF3250 capsules

  Evaluate changes in respiratory rate after using TQF3250 capsules

  Up to 24 hour

• Changes in blood pressure after using TQF3250 capsules

  To evaluate the changes in blood pressure after using TQF3250 capsules

  Up to 24 hour

• Changes in blood oxygen saturation after using TQF3250 capsules

  Evaluate changes in blood oxygen saturation after using TQF3250 capsules

  Up to 24 hour

Secondary Outcomes (8)

• Peak drug concentration (Cmax)

  Within 20 days after administration

• Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)

  Within 20 days after administration

• Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

  Within 20 days after administration

• Peak time (Tmax)

  Within 20 days after administration

• To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial

  Up to 20 days

Study Arms (2)

TQF3250 placebo

PLACEBO COMPARATOR

Placebo without drug substance.

Drug: TQF3250 placebo

TQF3250 capsule

EXPERIMENTAL

Oral administration, the fasting administration group was administered once, and the food-influenced group was administered once per cycle, for a total of two cycles. Each cycle is 10 days.

Drug: TQF3250 capsule

Interventions

TQF3250 placebo DRUG

TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.

TQF3250 placebo

TQF3250 capsule DRUG

TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.

TQF3250 capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese subjects aged above 18 years old (including 18 years old) and below 55 years old (including 55 years old);
• Those who voluntarily sign a written informed consent form before the trial, have a full understanding of the trial content, process and possible adverse reactions, can communicate well with the researcher, and understand and comply with the requirements of this study;
• Women of childbearing potential should agree to use effective contraceptive measures during the study and for 6 months after the end of the study;
• Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 20-40kg/m2 (including both ends of the cutoff);

You may not qualify if:

• Pregnant and lactating women.
• Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, anteroposterior chest X-ray, and abdominal ultrasound results during the screening period are abnormal and have clinical significance.
• Those who have had or currently have diseases/abnormalities such as heart, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, blood, nerve or mental illness, or related chronic diseases, or acute diseases, and the researcher assesses that they are not suitable to participate in the trial:
• Have active tuberculosis during the screening period, or be a close household contact of an untreated active tuberculosis patient.
• Have a history of severe bacterial, fungal or viral infection within 2 months before randomization, requiring hospitalization with intravenous antibiotics or antiviral drug treatment;
• Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;
• Subjects with any bleeding or bleeding events ≥ Common Terminology Criteria (CTC) AE grade 3 within 4 weeks before the first dose;
• Clinically significant infections occur during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, and require antibiotic or antiviral drug treatment.
• Have a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, and generalized herpes zoster.
• Use any systemic cytotoxic or systemic immunosuppressive drugs within 6 months before randomization or within the study period, or use any local cytotoxic or local immunosuppressive drugs within 4 weeks before randomization or within 5 half-lives (whichever is longer) or during the study period.
• Have received any other biological agents on the market or under investigation within 3 months or 5 half-lives (whichever is longer) before randomization.
• Have received a live vaccine within 4 weeks before randomization or plan to receive a live vaccine during the study.
• Those who have undergone surgery within 4 weeks before randomization, or plan to have surgery during the study period.
• Those who lost blood or donated more than 400 mL of blood within 4 weeks before randomization.
• Taking any prescription drugs, non-prescription drugs and herbal medicines within 4 weeks before randomization, except vitamin products.

Sponsors & Collaborators

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

Study Sites (1)

Drum Tower Hospital Affiliated to Nanjing University School of Medicine

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Juan Li, Doctor

CONTACT

15951989771; juanli2003@163.com

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: December 5, 2025
• First Posted: January 8, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-09

Locations

CN (1)