Actively Recruiting
A Phase Ia Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of TQF3250 Capsules in Healthy Adults with Hyperglycemia After Single and Escalating Oral Doses
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-01-08
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQF3250 capsules, a biased GLP-1 receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., in healthy adult subjects with hyperglycemia. This Phase 1a clinical trial aims to study the safety, tolerability, and pharmacokinetic characteristics of TQF3250 after single administration and escalating doses. The capsule selectively activates certain pathways of the GLP-1 receptor to potentially offer better effects with fewer side effects. Participants will be randomly assigned to receive either a TQF3250 capsule or placebo. The treatment involves oral administration in two cycles of 10 days each. One group will take the capsule while fasting once, and the other group will take it once per cycle after eating to assess the food's influence. The study uses quadruple masking to maintain blinding. During the study, participants will be monitored closely for adverse events, vital signs, electrocardiograms, and laboratory test results up to 20 days. Researchers will assess changes in body temperature, heart rate, respiratory rate, blood pressure, and blood oxygen levels within 24 hours of dosing. Pharmacokinetic measures such as peak drug concentration and drug exposure over time will also be evaluated. Participants are expected to comply with study procedures and dietary requirements throughout the trial.
CONDITIONS
Brief Title
A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese subjects aged 18 to 55 years inclusive
- Voluntarily sign informed consent and understand the study and possible adverse reactions
- Women of childbearing potential agree to use effective contraception during the study and for 6 months after
- Male weight at least 50 kg, female weight at least 45 kg
- Body mass index between 20 and 40 kg/m2 inclusive
You will not qualify if you...
- Pregnant or lactating women
- Abnormal vital signs or clinical exam results with clinical significance during screening
- History or presence of heart, endocrine, metabolic, kidney, liver, gastrointestinal, skin, infection, blood, nerve, mental, or related chronic or acute diseases deemed unsuitable by researchers
- Active tuberculosis or close contact with untreated active tuberculosis
- Severe infections requiring hospitalization within 2 months before randomization
- Major surgery, traumatic injury, or long-term unhealed wounds within 4 weeks before first medication
- Significant bleeding events within 4 weeks before first dose
- Clinically significant infections during screening requiring antibiotics or antivirals
- Severe herpes infections history
- Use of systemic immunosuppressive or cytotoxic drugs within 6 months before randomization
- Use of biological agents within 3 months before randomization
- Live vaccine use within 4 weeks before randomization or planned during study
- Surgery within 4 weeks before randomization or planned during study
- Blood donation over 400 mL within 4 weeks before randomization
- Use of prescription, non-prescription, or herbal drugs within 4 weeks before randomization except vitamins
- History of fainting from blood collection or difficulty collecting blood
- Allergy to TQF3250 capsule ingredients or severe drug allergy history
- History of drug abuse or positive drug screening
- Smoking over 5 cigarettes/day or nicotine use within 3 months before randomization or inability to stop during study
- Long-term alcoholism or drinking over 14 alcohol units per week within 3 months before screening or positive alcohol breath test
- Excessive caffeine intake within 4 weeks before screening
- Consumption of grapefruit, bitter orange, or their juice within 7 days before first dose or inability to stop during study
- Special dietary requirements preventing acceptance of standard diet
- Any other medical, mental, or social reasons preventing participation
- Inability to comply with study plan
- Participation in other clinical trials within 3 months before first medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 days
Participants receive oral doses of TQF3250 capsules or placebo in two cycles to assess safety and pharmacokinetics.
1 baseline visit and multiple follow-up visits during 20 days
Trial Site Locations
Total: 1 location
1
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
J
Juan Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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