DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07327281

RecruitingPhase 1

A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects

A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQF3250 Capsules in Healthy Adult Subjects After Single Administration and Escalating Doses

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

66

estimated

Study population

Healthy volunteers

Key I/E criterion

•BMI 20-40

Primary endpoints

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Abnormal clinical laboratory test indicators•Changes in body temperature after

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07327281
Org study IDTQF3250-Ia-01

Timeline

Milestones

Study start2025-12-18actual
Study first posted2026-01-08actual
Last update posted2026-01-08actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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);

Exclusion criteria

•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.
•Those who have difficulty collecting blood and have a history of fainting from needles or bleeding.
•Are allergic to any known ingredients of TQF3250 capsules, or have any history of severe drug allergy.
•Those with a history of drug abuse or positive urine drug screening.
•Those who smoke more than 5 cigarettes/day or use a considerable amount of nicotine or nicotine-containing products within 3 months before randomization, or who cannot stop using any tobacco products during the trial.
•Those who have been alcoholics for a long time or who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) within 3 months before screening, or who cannot abstain from alcohol during the test, or who have a positive alcohol breath test.
•Those who habitually consume too many caffeinated drinks or foods within 4 weeks before screening. Have consumed grapefruit, bitter orange and the juice of these fruits within 7 days before the first dose, or cannot stop consuming grapefruit, bitter orange and the juice of these fruits during the study;
•Those who have special dietary requirements and cannot accept standard diet;
•There are any other reasonable medical, mental or social reasons that the researcher believes to be unable to participate in this study.
•Those who are unable to comply with the trial plan;
•Those who participated in and used other clinical trial drugs within three months before the first medication;

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
12
Cardiometabolic biomarkers
2
Other clinical outcomes
1
Other (unclassified)
1

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Changes in pulse/heart rate after use of TQF3250 capsules

Time frame:Up to 24 hour

Heart rate, change

change from baseline, improvement

Primary/protocol endpoint

Changes in blood pressure after using TQF3250 capsules

Time frame:Up to 24 hour

change from baseline, improvement

Safety / tolerability / PK

12 endpoints
Primary/protocol endpoint

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 days

Treatment-emergent AEs (any)

descriptive, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Primary/protocol endpoint

Number of participants with abnormal clinical laboratory test indicators

Time frame:Up to 20 days

event count, event

Primary/protocol endpoint

Tolerance assessment: 12-lead electrocardiogram

Time frame:Up to 20 days

descriptive

Primary/protocol endpoint

Changes in respiratory rate after using TQF3250 capsules

Time frame:Up to 24 hour

change from baseline, descriptive

Secondary/protocol endpoint

Peak drug concentration (Cmax)

Time frame:Within 20 days after administration

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Within 20 days after administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Within 20 days after administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Peak time (Tmax)

Time frame:Within 20 days after administration

Tmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to 20 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to 20 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial

Time frame:Up to 20 days

Cmax

concentration, descriptive

Secondary/protocol endpoint/low confidence

Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites

Time frame:Up to 20 days

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Changes in blood oxygen saturation after using TQF3250 capsules

Time frame:Up to 24 hour

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint

Changes in body temperature after using TQF3250 capsules

Time frame:Up to 24 hour

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.