HealthyPhase 1NCT07123428
Single and Multiple Ascending Doses and Food Effect Study of TRD205 in Healthy Volunteers
A Phase 1 study testing TRD205 in people with Healthy, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of TRD205 after single and multiple doses and to evaluate the effect of food on TRD205 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TRD205
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to 27 Feb 2025
- 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
- Subjects who can understand the requirements and potential side effects of the study and voluntarily sign the informed consent form.
- Able to complete the study per protocol and communicate with the investigators.
- Subjects (and their sexual partners) should voluntarily practice effective contraception per protocol.
- Healthy subjects aged 18-55 years.
- Body weight should be ≥ 50 kg for male subjects and ≥ 45 kg for female subjects with a body mass index of 18-28 kg/m2.
- Physical examination and vital sign: normal or are considered by the investigator to be of no clinical significance.
- No vaccination within 30 days prior to screening.
Who cannot join
- Smoking 5 or more cigarettes per day within 3 months before screening.
- Subjects with an allergic constitution, such as a history of allergy to two or more drugs or food.
- Subjects who have a history of drug abuse and or alcoholism.
- Subjects who have had blood donation and/or blood loss ≥ 450 mL wihin 3 months before screening.
- Subjects who have consumed medications known to alter hepatic drug metabolism enzyme activity within 28 days before screening.
- Subjects who have taken any other prescription medication, OTC products, vitamins or herbal products within 14 days before screening, except for those exempted by the investigator on a case-by-case basis.
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- Subjects who have eaten special food, such as dragon fruit, mango, pomelo, grapefruit, cranberry and their juice, or had vigorous exercise, or had other factors that may influence the ADME process of drug.
- Subjects who have concomitant drugs that induce or inhibit CYP3A4, P-gp, Bcrp.
- Subjects who have consumed investigational products or participated in drug clinical trials within 3 months before taking IP.
- Subjects who have dysphagia or other gastrointestinal diseases that can influence drug adsorption.
- Subjects who can not tolerate the standard meal (just for those who participate the food effect study).
- 12-lead ECG: abnormal results and considered by the investigator to be of clinical significance.
- Pregnant or lactating women.
- Laboratory tests: abnormal results and considered by the investigator to be of clinical significance. Or subjects with the diseases of gastrointestinal tract, kidney, liver, nervous system, blood system, endocrinal system, tumor, lung, immunity, mental system, cardiovascular system, cerebral vascular system within 12 months before screening.
- Positive serological tests for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and treponema pallidum (TP) at screening.
- Subjects who have had acute disease or concomitant drugs from screening to taking IP.
- Subjects who have consumed chocolate, Caffeine-containing products or xanthine containing food (such as tea, coffee, colar) within 48 hours beforing taking IP.
- Subjects who have consumed alcohol-containing products within 48 hours beforing taking IP.
- Subjects who have a positive urine drug screening test result.
- Subject who have received surgery within 4 weeks before taking IP.
- Subject who are not ready to abstain from participation in any other clinical study for the duration of this study and for 30 days or more (as required by the investigator) after completion of the study.
- Mental or physical disability.
- Subject cannot tolerate venipuncture blood collection or has a history of sickness at the sight of blood and/or needle.
- Any reason that, in the opinion of the Investigator, may prevent the subject from participating in the study.
- Subjects who have the risk factors of torsade de pointes, or a family history of a first-degree relative with short QT syndrome, long QT syndrome, unexplained sudden death in youth, drowning, or sudden infant death syndrome.
- Subjects with abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of and Food Effect on TRD205 After Single and Multiple Doses in Healthy Adult Subjects
This is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of TRD205 after single and multiple doses and to evaluate the effect of food on TRD205 in healthy adult subjects.
Read the detailed description
This study consists of three parts:
- Single ascending dose study
- Multiple ascending dose study
- Food effect study
- Conditions
- Healthy
- Being tested
- TRD205, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRD205Drug
TRD205 tablet
PlaceboDrug
TRD205 placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| TRD205: Single ascending dose (SAD) study | Experimental | TRD205: oral, single ascending doses up to 7 doses levels. Receives: Drug: TRD205 |
| Placebo: Single ascending dose (SAD) study | Placebo comparator | Placebo: oral, TRD205 placebo in single ascending doses study. Receives: Drug: Placebo |
| TRD205: Food effect study | Experimental | TRD205: oral, just 1 dose under fasted or fed condition for each period. Receives: Drug: TRD205 |
| Placebo: Food effect study | Placebo comparator | Placebo: oral, under fasted or fed condition for each period. Receives: Drug: Placebo |
| Multiple ascending dose (MAD) study | Experimental | TRD205: oral, multiple ascending doses up to 4 doses levels. Doses and dosing frequency will be decided based on SAD results. Receives: Drug: TRD205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Adverse Events
The safety and tolerability of TRD205 orally administered once and/or multiple times on an empty stomach in healthy subjects
Measured: After a single dose and/or once daily for 10 consecutive doses
Secondary outcomes (7)
Area under the plasma concentration versus time curve （AUC）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
Peak Plasma Concentration（Cmax）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
time to peak（Tmax）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
Elimination rate constant（Kel）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
apparent volume of distribution（Vd）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
elimination half life（T1/2）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
Mean retention time（MRT）
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Measured: After a single dose and/or once daily for 10 consecutive doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start26 Jan 2024
- Primary completion27 Nov 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123428
- Sponsor's protocol ID
- TRD205-Ⅰ-01
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2024
- Last updated
- 14 Aug 2025
- Results posted
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of and Food Effect on TRD205 After Single and Multiple Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07123428
- Acronym / sponsor ID
- TRD205-Ⅰ-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 14 Aug 2025 (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.
This is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of TRD205 after single and multiple doses and to evaluate the effect of food on TRD205 in healthy adult subjects.
Detailed description
This study consists of three parts:
- Single ascending dose study
- Multiple ascending dose study
- Food effect study
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TRD205: Single ascending dose (SAD) study | Experimental | Drug: TRD205TRD205: oral, single ascending doses up to 7 doses levels. |
| Placebo: Single ascending dose (SAD) study | Placebo comparator | Drug: PlaceboPlacebo: oral, TRD205 placebo in single ascending doses study. |
| TRD205: Food effect study | Experimental | Drug: TRD205TRD205: oral, just 1 dose under fasted or fed condition for each period. |
| Placebo: Food effect study | Placebo comparator | Drug: PlaceboPlacebo: oral, under fasted or fed condition for each period. |
| Multiple ascending dose (MAD) study | Experimental | Drug: TRD205TRD205: oral, multiple ascending doses up to 4 doses levels. Doses and dosing frequency will be decided based on SAD results. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who can understand the requirements and potential side effects of the study and voluntarily sign the informed consent form.
Key exclusion criteria (26 listed)
- Smoking 5 or more cigarettes per day within 3 months before screening.
- Subjects with an allergic constitution, such as a history of allergy to two or more drugs or food.
- Subjects who have a history of drug abuse and or alcoholism.
- Subjects who have had blood donation and/or blood loss ≥ 450 mL wihin 3 months before screening.
- Subjects who have consumed medications known to alter hepatic drug metabolism enzyme activity within 28 days before screening.
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 |
|---|---|---|
| TRD205TRD205 tablet | Drug | Multiple ascending dose (MAD) study, TRD205: Food effect study, TRD205: Single ascending dose (SAD) study |
| PlaceboTRD205 placebo tablet | Drug | Placebo: Food effect study, Placebo: Single ascending dose (SAD) study |
Primary outcome
Treatment-Related Adverse Events
Time frame: After a single dose and/or once daily for 10 consecutive doses
The safety and tolerability of TRD205 orally administered once and/or multiple times on an empty stomach in healthy subjects
7 secondary outcomes
Area under the plasma concentration versus time curve （AUC）
Time frame: After a single dose and/or once daily for 10 consecutive doses
Peak Plasma Concentration（Cmax）
Time frame: After a single dose and/or once daily for 10 consecutive doses
time to peak（Tmax）
Time frame: After a single dose and/or once daily for 10 consecutive doses
Elimination rate constant（Kel）
Time frame: After a single dose and/or once daily for 10 consecutive doses
apparent volume of distribution（Vd）
Time frame: After a single dose and/or once daily for 10 consecutive doses
elimination half life（T1/2）
Time frame: After a single dose and/or once daily for 10 consecutive doses
Mean retention time（MRT）
Time frame: After a single dose and/or once daily for 10 consecutive doses
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 14 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 TRD205 in people with Healthy, run by Beijing Tide Pharmaceutical 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 7 inclusion and 26 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 14 Aug 2025. 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-Related Adverse Events (time frame: After a single dose and/or once daily for 10 consecutive doses). 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 14 Aug 2025.