CompletedNCT07123428Updated Aug 14, 2025

Single and Multiple Ascending Doses and Food Effect Study of TRD205 in Healthy Volunteers

A Phase 1 interventional study of TRD205 and Placebo in Healthy, sponsored by Beijing Tide Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Beijing Tide Pharmaceutical Co., Ltd · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 151
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 the detailed description

This study consists of three parts:

Single ascending dose study
Multiple ascending dose study
Food effect study

Conditions studied

Healthy

In context

Lead sponsor

Beijing Tide Pharmaceutical Co., Ltd is the lead sponsor of 14 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 151 participants (actual)

Study arms

Experimental
TRD205: Single ascending dose (SAD) study
TRD205: oral, single ascending doses up to 7 doses levels.
Drug: TRD205
Placebo comparator
Placebo: Single ascending dose (SAD) study
Placebo: oral, TRD205 placebo in single ascending doses study.
Drug: Placebo
Experimental
TRD205: Food effect study
TRD205: oral, just 1 dose under fasted or fed condition for each period.
Drug: TRD205
Placebo comparator
Placebo: Food effect study
Placebo: oral, under fasted or fed condition for each period.
Drug: Placebo
Experimental
Multiple ascending dose (MAD) study
TRD205: oral, multiple ascending doses up to 4 doses levels. Doses and dosing frequency will be decided based on SAD results.
Drug: TRD205

Interventions

DrugTRD205
TRD205 tablet
DrugPlacebo
TRD205 placebo tablet

What researchers measure

Primary outcomes

Treatment-Related Adverse Events
The safety and tolerability of TRD205 orally administered once and/or multiple times on an empty stomach in healthy subjects
Time frame: After a single dose and/or once daily for 10 consecutive doses

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After a single dose and/or once daily for 10 consecutive doses

Study locations

1 site

The first hospital of Jilin University
Changchun, Jilin 130021, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07123428
Lead sponsor: Beijing Tide Pharmaceutical Co., Ltd
Responsible party: Sponsor
First posted: Aug 14, 2025
Start date: Jan 26, 2024
Primary completion: Nov 27, 2024
Completion: Feb 27, 2025
Last update: Aug 14, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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