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

Qualifiers

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

Treatments tested in this trial

TQF3250 placebo
TQF3250 capsule

Treatment groups

66 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov