Healthy SubjectsPhase 1NCT07394452
Single Ascending Dose Study(SAD),Multiple Ascending Dose Study(MAD) , High-fat Diet Study (FE) of TJ0113 Capsules in Healthy Subjects
A Phase 1 study testing TJ0113 Capsules in people with Healthy Subjects, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TJ0113 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 3 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Subjects who have used any known hepatic enzyme inducers or inhibitors within 30 days before the first dose;
- Subjects with drug addiction or positive drug abuse tests, or a history of drug abuse/dependence or drug use within 1 year before screening;
- Subjects with positive results on infectious disease screening, including positive human immunodeficiency virus (HIV) antigen/antibody, positive hepatitis B surface antigen (HBsAg) quantification, positive hepatitis C virus (HCV) antibody, positive Treponema pallidum antibody tests;
- Subjects with positive pregnancy tests at screening or baseline, who are pregnant, breastfeeding, or planning to become pregnant during the trial, or men or women of childbearing potential who are unwilling to use effective contraception for 6 months after the last dose;
- Subjects who are unable to comply with all requirements of the study or still need to engage in or plan to participate in strenuous physical activity or exercise during the trial, including body contact or collision sports;
- Subjects who have participated in other clinical trials of drugs or medical devices within 3 months before screening, and received investigational products or medical devices; or planned to participate in other trials during the study period; or within 5 half-lives of another drug before screening (if 5 half-lives exceed 3 months);
- Employees or related personnel of the investigator, study site, sponsor, or contract research organization (CRO).Subjects who have other conditions that could impact compliance in the opinion of the investigator or who are unable to participate in the trial due to personal reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TJ0113 Capsules Administered Orally as Single Dose, Multiple Doses, and Doses in the Fed State in Healthy Subjects
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.
Read the detailed description
Study 1: SAD study A single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ0113 capsules in healthy subjects. Six dose groups (A1-A6) were established, with doses of 80 mg, 160 mg, 260 mg, 400 mg, 540 mg, and 720 mg, respectively.
A total of 72 healthy adult subjects (12 per group) were enrolled, including both males and females. Subjects in each dose group were randomized in a 5:1 ratio to receive either the investigational product, TJ0113 capsules, or placebo (10 subjects received the investigational product and 2 subjects received placebo). Two subjects in the 80 mg dose group were set as a sentinel arm and were randomized in a 1:1 ratio to receive either TJ0113 capsules or placebo. After completing the 24-hour safety observation following sentinel dosing, the remaining 10 subjects in the 80 mg dose group were randomized in a 9:1 ratio to receive either TJ0113 capsules or placebo.
Study 2: MAD study In the single-center, randomized, double-blind, placebo-controlled, MAD study of TJ0113 capsules in healthy subjects, 3 dose groups (B1 to B3) of 200 mg once daily(QD), 400 mg QD, 300 mg twice daily(BID )were set.
A total of 36 healthy adult subjects (12 per group) were enrolled, including both males and females. Subjects in each dose group were randomized in a 5:1 ratio to receive either the investigational product, TJ0113 capsules, or placebo (10 subjects received the investigational product and 2 subjects received placebo). Subjects in the 200 mg and 400 mg dose groups received once-daily (QD) dosing, while subjects in the 300 mg BID dose group received twice-daily (BID) dosing administered with warm water, for 7 consecutive days (only one dose in the morning on Day 7).
Study 3: FE study A single-center, single-dose, randomized, open-label, 2-sequence, 2-period, crossover study to evaluate the effect of a standard high-fat diet on the pharmacokinetics of TJ0113 capsules after single oral administration (200 mg) in healthy subjects.
A total of 20 healthy adult subjects were enrolled in this period and randomized in a 1:1 ratio to 2 dosing sequences (C1: fasting-fed; C2: fed-fasting), with 10 subjects per group (all receiving the investigational product TJ0113 capsule). Each dosing sequence consisted of 2 cycles with 1 dose administered in each cycle. Group C1 received the dose in a fasting state during the first cycle and in a fed state during the second cycle; Group C2 received the dose in a fed state during the first cycle and in a fasting state during the second cycle . The two cycles were separated by a 7-day washout period.
- Conditions
- Healthy Subjects
- Being tested
- TJ0113 Capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ0113 CapsulesDrug
Participants will receive oral administration of TJ0113.
PlaceboOther
Participants will receive oral administration of Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD): 80 mg | Experimental | Participants will receive single oral administration of 80 mg TJ0113. Receives: Drug: TJ0113 Capsules |
| Single Ascending Dose (SAD): 160 mg | Experimental | Participants will receive single oral administration of 160 mg TJ0113. Receives: Drug: TJ0113 Capsules |
| Single Ascending Dose (SAD): 260 mg | Experimental | Participants will receive single oral administration of 260 mg TJ0113. Receives: Drug: TJ0113 Capsules |
| Single Ascending Dose (SAD): 400 mg | Experimental | Participants will receive single oral administration of 400 mg TJ0113. Receives: Drug: TJ0113 Capsules |
| Single Ascending Dose (SAD): 540 mg | Experimental | Participants will receive single oral administration of 540 mg TJ0113. Receives: Drug: TJ0113 Capsules |
| Single Ascending Dose (SAD): 720 mg | Experimental | Participants will receive single oral administration of 720 mg TJ0113. Receives: Drug: TJ0113 Capsules |
| Single Ascending Dose (SAD): placebo | Placebo comparator | Participants will receive single oral administration of Placebo. Receives: Other: Placebo |
| Multiple Ascending Dose (MAD): 200 mg QD | Experimental | Participants will receive oral administration of 200 mg TJ0113 once daily for 7 days Receives: 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 Receives: 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 Receives: Drug: TJ0113 Capsules |
| Multiple Ascending Dose (MAD): placebo | Placebo comparator | Participants will receive oral administration of placebo for 7 days Receives: 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. Receives: 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. Receives: Drug: TJ0113 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: Within 12 days after the last administration
Secondary outcomes (13)
Maximum concentration (Cmax) of TJ0113 capsules after oral administration in SAD study
PK parameters for the SAD study mainly included maximum concentration (Cmax)
Measured: 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
PK parameters for the SAD study mainly included area under the plasma concentration versus time curve (AUC)
Measured: Within 72 hours after the last administration
Half life（t1/2） of TJ0113 capsules after oral administration in SAD study
PK parameters for the food effect study mainly included half life（t1/2）
Measured: Within 72 hours after the last administration
Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration in SAD study
PK parameters for the food effect study mainly included time to maximum
Measured: Within 72 hours after the last administration
Maximum concentration (Cmax) of TJ0113 capsules after oral administration in MAD study
PK parameters for the MAD study mainly included maximum concentration (Cmax)
Measured: Within 72 hours after the last administration
Area under the plasma concentration versus time curve (AUC) of TJ0113 capsules after oral administration in MAD study
PK parameters for the MAD study mainly included area under the plasma concentration versus time curve (AUC)
Measured: Within 72 hours after the last administration
Half life（t1/2） of TJ0113 capsules after oral administration in MAD study
PK parameters for the food effect study mainly included half life（t1/2）
Measured: Within 72 hours after the last administration
Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration in MAD study
PK parameters for the food effect study mainly included time to maximum
Measured: Within 72 hours after the last administration
Maximum concentration (Cmax) of TJ0113 capsules after oral administration with a standard high-fat diet in FE
PK parameters for the FE study mainly included maximum concentration (Cmax)
Measured: Within 72 hours after the last administration
Area under the plasma concentration versus time curve (AUC) of TJ0113 capsules after oral administration with a standard high-fat diet in FE study
PK parameters for the FE study mainly included area under the plasma concentration versus time curve (AUC)
Measured: Within 72 hours after the last administration
Half life（t1/2） of TJ0113 capsules after oral administration with a standard high-fat diet in FE study
PK parameters for the food effect study mainly included half life（t1/2）
Measured: Within 72 hours after the last administration
Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration with a standard high-fat diet in FE study
PK parameters for the food effect study mainly included time to maximum
Measured: Within 72 hours after the last administration
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after multiple oral administration with a standard high-fat diet in FE 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.)
Measured: Within 15 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start4 Aug 2023
- Primary completion5 Feb 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou PhecdaMed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Chen, Principal investigator, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394452
- Sponsor's protocol ID
- TJJS01-001
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TJ0113 Capsules Administered Orally as Single Dose, Multiple Doses, and Doses in the Fed State in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07394452
- Acronym / sponsor ID
- TJJS01-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hangzhou PhecdaMed Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study 1: SAD study A single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ0113 capsules in healthy subjects. Six dose groups (A1-A6) were established, with doses of 80 mg, 160 mg, 260 mg, 400 mg, 540 mg, and 720 mg, respectively.
A total of 72 healthy adult subjects (12 per group) were enrolled, including both males and females. Subjects in each dose group were randomized in a 5:1 ratio to receive either the investigational product, TJ0113 capsules, or placebo (10 subjects received the investigational product and 2 subjects received placebo). Two subjects in the 80 mg dose group were set as a sentinel arm and were randomized in a 1:1 ratio to receive either TJ0113 capsules or placebo. After completing the 24-hour safety observation following sentinel dosing, the remaining 10 subjects in the 80 mg dose group were randomized in a 9:1 ratio to receive either TJ0113 capsules or placebo.
Study 2: MAD study In the single-center, randomized, double-blind, placebo-controlled, MAD study of TJ0113 capsules in healthy subjects, 3 dose groups (B1 to B3) of 200 mg once daily(QD), 400 mg QD, 300 mg twice daily(BID )were set.
A total of 36 healthy adult subjects (12 per group) were enrolled, including both males and females. Subjects in each dose group were randomized in a 5:1 ratio to receive either the investigational product, TJ0113 capsules, or placebo (10 subjects received the investigational product and 2 subjects received placebo). Subjects in the 200 mg and 400 mg dose groups received once-daily (QD) dosing, while subjects in the 300 mg BID dose group received twice-daily (BID) dosing administered with warm water, for 7 consecutive days (only one dose in the morning on Day 7).
Study 3: FE study A single-center, single-dose, randomized, open-label, 2-sequence, 2-period, crossover study to evaluate the effect of a standard high-fat diet on the pharmacokinetics of TJ0113 capsules after single oral administration (200 mg) in healthy subjects.
A total of 20 healthy adult subjects were enrolled in this period and randomized in a 1:1 ratio to 2 dosing sequences (C1: fasting-fed; C2: fed-fasting), with 10 subjects per group (all receiving the investigational product TJ0113 capsule). Each dosing sequence consisted of 2 cycles with 1 dose administered in each cycle. Group C1 received the dose in a fasting state during the first cycle and in a fed state during the second cycle; Group C2 received the dose in a fed state during the first cycle and in a fasting state during the second cycle . The two cycles were separated by a 7-day washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD): 80 mg | Experimental | Drug: TJ0113 CapsulesParticipants will receive single oral administration of 80 mg TJ0113. |
| Single Ascending Dose (SAD): 160 mg | Experimental | Drug: TJ0113 CapsulesParticipants will receive single oral administration of 160 mg TJ0113. |
| Single Ascending Dose (SAD): 260 mg | Experimental | Drug: TJ0113 CapsulesParticipants will receive single oral administration of 260 mg TJ0113. |
| Single Ascending Dose (SAD): 400 mg | Experimental | Drug: TJ0113 CapsulesParticipants will receive single oral administration of 400 mg TJ0113. |
| Single Ascending Dose (SAD): 540 mg | Experimental | Drug: TJ0113 CapsulesParticipants will receive single oral administration of 540 mg TJ0113. |
| Single Ascending Dose (SAD): 720 mg | Experimental | Drug: TJ0113 CapsulesParticipants will receive single oral administration of 720 mg TJ0113. |
| Single Ascending Dose (SAD): placebo | Placebo comparator | Other: PlaceboParticipants will receive single oral administration of Placebo. |
| Multiple Ascending Dose (MAD): 200 mg QD | Experimental | Drug: TJ0113 CapsulesParticipants will receive oral administration of 200 mg TJ0113 once daily for 7 days |
| Multiple Ascending Dose (MAD): 400 mg QD | Experimental | Drug: TJ0113 CapsulesParticipants will receive oral administration of 400 mg TJ0113 once daily for 7 days |
| Multiple Ascending Dose (MAD): 300 mg BID | Experimental | Drug: TJ0113 CapsulesParticipants will receive oral administration of 300 mg TJ0113 twice daily for 7 days |
| Multiple Ascending Dose (MAD): placebo | Placebo comparator | Other: PlaceboParticipants will receive oral administration of placebo for 7 days |
| Food Effect: 200 mg C1: fasting-fed | Experimental | Drug: TJ0113 CapsulesGroup 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. |
| Food Effect: 200 mg C2: fed-fasting | Experimental | Drug: TJ0113 CapsulesGroup 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ0113 CapsulesParticipants will receive oral administration of TJ0113. | Drug | 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 |
| PlaceboParticipants will receive oral administration of Placebo. | Other | Multiple Ascending Dose (MAD): placebo, Single Ascending Dose (SAD): placebo |
Primary outcome
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after single oral administration in SAD study
Time frame: Within 12 days after the last administration
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.)
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after multiple oral administration in MAD study
Time frame: Within 12 days after the last administration
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.)
13 secondary outcomes
Maximum concentration (Cmax) of TJ0113 capsules after oral administration in SAD study
Time frame: 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
Time frame: Within 72 hours after the last administration
Half life（t1/2） of TJ0113 capsules after oral administration in SAD study
Time frame: Within 72 hours after the last administration
Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration in SAD study
Time frame: Within 72 hours after the last administration
Maximum concentration (Cmax) of TJ0113 capsules after oral administration in MAD study
Time frame: Within 72 hours after the last administration
Area under the plasma concentration versus time curve (AUC) of TJ0113 capsules after oral administration in MAD study
Time frame: Within 72 hours after the last administration
Half life（t1/2） of TJ0113 capsules after oral administration in MAD study
Time frame: Within 72 hours after the last administration
Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration in MAD study
Time frame: Within 72 hours after the last administration
Maximum concentration (Cmax) of TJ0113 capsules after oral administration with a standard high-fat diet in FE
Time frame: Within 72 hours after the last administration
Area under the plasma concentration versus time curve (AUC) of TJ0113 capsules after oral administration with a standard high-fat diet in FE study
Time frame: Within 72 hours after the last administration
Half life（t1/2） of TJ0113 capsules after oral administration with a standard high-fat diet in FE study
Time frame: Within 72 hours after the last administration
Time to maximum concentration (Tmax) of TJ0113 capsules after oral administration with a standard high-fat diet in FE study
Time frame: Within 72 hours after the last administration
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after multiple oral administration with a standard high-fat diet in FE study
Time frame: Within 15 days after the last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Chen principal investigator
Zhejiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TJ0113 Capsules in people with Healthy Subjects, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after single oral administration in SAD study (time frame: Within 12 days after the last administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.