Single Ascending Dose Study(SAD),Multiple Ascending Dose Study(MAD) , High-fat Diet Study (FE) of TJ0113 Capsules in Healthy Subjects

NCT07394452 | Completed Phase 1

• 1 other identifier: TJJS01-001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The study included three clinical studies, namely a single ascending dose (SAD) study, a multiple ascending dose (MAD) study, and a high-fat diet food effect (FE) study.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after single oral administration in SAD study

  Types, incidence rates, and severity of adverse events. Safety evaluation indicators include, but are not limited to, the following items: adverse events, physical examination, vital signs, electrocardiogram (ECG), laboratory test results (coagulation function, complete blood count, blood biochemistry, urinalysis plus urine specific gravity, etc.)

  Within 12 days after the last administration

• Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after multiple oral administration in MAD study

  Types, incidence rates, and severity of adverse events. Safety evaluation indicators include, but are not limited to, the following items: adverse events, physical examination, vital signs, electrocardiogram (ECG), laboratory test results (coagulation function, complete blood count, blood biochemistry, urinalysis plus urine specific gravity, etc.)

  Within 12 days after the last administration

Secondary Outcomes (13)

• Maximum concentration (Cmax) of TJ0113 capsules after oral administration in SAD study

  Within 72 hours after the last administration

• Area under the plasma concentration versus time curve (AUC) of TJ0113 capsules after oral administration in SAD study

  Within 72 hours after the last administration

• Half life（t1/2） of TJ0113 capsules after oral administration in SAD study

  Within 72 hours after the last administration

• Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration in SAD study

  Within 72 hours after the last administration

• Maximum concentration (Cmax) of TJ0113 capsules after oral administration in MAD study

  Within 72 hours after the last administration

Study Arms (13)

Single Ascending Dose (SAD): 80 mg

EXPERIMENTAL

Participants will receive single oral administration of 80 mg TJ0113.

Drug: TJ0113 Capsules

Single Ascending Dose (SAD): 160 mg

EXPERIMENTAL

Participants will receive single oral administration of 160 mg TJ0113.

Drug: TJ0113 Capsules

Single Ascending Dose (SAD): 260 mg

EXPERIMENTAL

Participants will receive single oral administration of 260 mg TJ0113.

Drug: TJ0113 Capsules

Single Ascending Dose (SAD): 400 mg

EXPERIMENTAL

Participants will receive single oral administration of 400 mg TJ0113.

Drug: TJ0113 Capsules

Single Ascending Dose (SAD): 540 mg

EXPERIMENTAL

Participants will receive single oral administration of 540 mg TJ0113.

Drug: TJ0113 Capsules

Single Ascending Dose (SAD): 720 mg

EXPERIMENTAL

Participants will receive single oral administration of 720 mg TJ0113.

Drug: TJ0113 Capsules

Single Ascending Dose (SAD): placebo

PLACEBO COMPARATOR

Participants will receive single oral administration of Placebo.

Other: Placebo

Multiple Ascending Dose (MAD): 200 mg QD

EXPERIMENTAL

Participants will receive oral administration of 200 mg TJ0113 once daily for 7 days

Drug: TJ0113 Capsules

Multiple Ascending Dose (MAD): 400 mg QD

EXPERIMENTAL

Participants will receive oral administration of 400 mg TJ0113 once daily for 7 days

Drug: TJ0113 Capsules

Multiple Ascending Dose (MAD): 300 mg BID

EXPERIMENTAL

Participants will receive oral administration of 300 mg TJ0113 twice daily for 7 days

Drug: TJ0113 Capsules

Multiple Ascending Dose (MAD): placebo

PLACEBO COMPARATOR

Participants will receive oral administration of placebo for 7 days

Other: Placebo

Food Effect: 200 mg C1: fasting-fed

EXPERIMENTAL

Group C1 received oral administration of 200 mg TJ0113 once in a fasting state during the first cycle and received oral administration of 200 mg TJ0113 once in a fed state during the second cycle. The two cycles were separated by a 7-day washout period.

Drug: TJ0113 Capsules

Food Effect: 200 mg C2: fed-fasting

EXPERIMENTAL

Group C2 received oral administration of 200 mg TJ0113 once in a fed state during the first cycle and received oral administration of 200 mg TJ0113 once in a fasting state during the second cycle. The two cycles were separated by a 7-day washout period.

Drug: TJ0113 Capsules

Interventions

TJ0113 Capsules DRUG

Participants will receive oral administration of TJ0113.

Food Effect: 200 mg C1: fasting-fed; Food Effect: 200 mg C2: fed-fasting; Multiple Ascending Dose (MAD): 200 mg QD; Multiple Ascending Dose (MAD): 300 mg BID; Multiple Ascending Dose (MAD): 400 mg QD; Single Ascending Dose (SAD): 160 mg; Single Ascending Dose (SAD): 260 mg; Single Ascending Dose (SAD): 400 mg; Single Ascending Dose (SAD): 540 mg; Single Ascending Dose (SAD): 720 mg; Single Ascending Dose (SAD): 80 mg

Placebo OTHER

Participants will receive oral administration of Placebo.

Multiple Ascending Dose (MAD): placebo; Single Ascending Dose (SAD): placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily participate in the clinical trial, sign the informed consent form, understand and agree to follow the protocol, have a full understanding of trial contents, process, and possible adverse reactions, and indicate the date of signing;
• Aged 18 \~ 55 years (inclusive), Chinese healthy male or female;
• Body weight ≥ 50 kg (male) or ≥ 45 kg (female), body mass index (BMI) within the range of 19.0 \~ 26.0 kg/m2 (inclusive);
• Subjects and their partners have no plans for pregnancy, donation of sperm or eggs, and voluntarily take effective contraceptive measures (such as abstinence, condom, etc.) from the screening phase until 6 months after the end of the trial;
• Able to communicate well with the investigator, understand and agree to follow all requirements of this trial.

You may not qualify if:

• Subjects with a history or current presence of chronic diseases involving the cardiovascular, respiratory, urinary, nervous, psychiatric, hematological, endocrine and metabolic (diabetes, thyroid disease, adrenal disease), and immune systems, and deemed unsuitable for participation by the investigator.
• Subjects who have received surgery within 3 months before screening, or plan to receive surgery during the trial; or have received medical or surgical treatment (such as gastrointestinal surgery) permanently changing the absorption, distribution, metabolism and excretion of oral drugs (except for hernia repair); a history of abdominal surgery, such as cholecystectomy (except for uncomplicated appendectomy and endoscopic treatment of gastrointestinal polyps after 6 months);
• Subjects with dysphagia or gastrointestinal, liver, or kidney diseases (regardless of whether they have been cured) within 6 months before screening that could affect drug absorption or excretion;
• History of clinically significant drug allergy or specific allergic diseases (such as asthma, urticaria) or known hypersensitivity to the investigational product or its excipients;
• Subjects who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or supplements within 14 days before the first dose;
• Subjects with abnormal and clinically significant results on physical examination, vital signs, laboratory tests (blood routine test, urinalysis + specific gravity, blood biochemistry, coagulation function, etc.) at screening and baseline;
• Subjects with clinically significant 12-lead ECG abnormalities at screening or baseline, or with an average QTcF (corrected QT interval using Fridericia's formula) \>450 ms for males, \>470 ms for females, QRS \>120 ms, or a history of long QT syndrome.
• Subjects who have special dietary requirements and cannot abide by the standard diet;
• Subjects who are difficult to collect blood samples or cannot tolerate venipuncture, and have a history of fainting at the sight of blood or needles;
• Subjects who have blood donation or non-physiological blood loss ≥ 400 mL (including trauma, blood collection, blood donation, etc., except for physiological blood loss in females) within 3 months before screening, or blood transfusion; or blood donation or non-physiological blood loss ≥ 200 mL within 1 month before screening; or blood donation or blood components planned during the study or within 3 months after the end of the study;
• Subjects who have excessively used nicotine products (more than 5 cigarettes in average daily) within 3 months before screening and cannot stop using any tobacco products throughout the trial; subjects with positive urine cotinine tests;
• Subjects who have consumed more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), have a positive alcohol breath test at baseline (breath alcohol content \>0.0 mg/100 mL), or cannot abstain from alcohol during the trial;
• Subjects who have long-term excessive consumption of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 200 mL) within the year prior to screening; subjects who have consumed any foods or beverages containing caffeine, alcohol, xanthine, or grapefruit components, or other substances that affect drug absorption, distribution, metabolism, and excretion (such as coffee, tea, chocolate, etc.) within 48 hours before the first dose;
• Subjects who have received live vaccine inoculations within 14 days before screening or plan to receive them during the trial or within 1 month after dosing, including but not limited to measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin Vaccine (BCG), typhoid vaccine, COVID-19 vaccine, etc.;
• Subjects who have febrile illness or active infection within 14 days before screening;

Sponsors & Collaborators

• Hangzhou PhecdaMed Co., Ltd.: lead

Study Sites (1)

Zhejiang Xiaoshan hospital

Hangzhou, Zhejiang, 310009, China

Location

Study Officials

• Jian Chen

  Zhejiang Hospital

  PRINCIPAL INVESTIGATOR

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: January 26, 2026
• First Posted: February 6, 2026
• Study Start: August 4, 2023
• Primary Completion: February 5, 2024
• Study Completion: April 3, 2024
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)