A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects
ConditionHyperglycemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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.
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;
Trial design
Design model
Parallel
Treatments tested in this trial
TQF3250 placebo
DrugTQF3250 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
DrugTQF3250 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: TQF3250 placeboPlacebo comparator 1 intervention
Group B: TQF3250 capsuleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 20 days2
Number of participants with abnormal clinical laboratory test indicators
Number of participants with abnormal clinical laboratory test indicators.
Time frame
Up to 20 days3
Changes in body temperature after using TQF3250 capsules
Evaluate changes in body temperature after using TQF3250 capsules
Time frame
Up to 24 hour4
Tolerance assessment: 12-lead electrocardiogram
Tolerance assessment: 12-lead electrocardiogram
Time frame
Up to 20 daysSecondary outcomes
1
Peak drug concentration (Cmax)
It refers to the highest blood concentration reached after administration of TQF3250 capsules.
Time frame
Within 20 days after administration2
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t).
Time frame
Within 20 days after administration3
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞).
Time frame
Within 20 days after administration4
Peak time (Tmax)
It refers to the time it takes for TQF3250 capsules to reach the highest blood concentration after administration.
Time frame
Within 20 days after administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov