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

NCT07123428 | Completed Phase 1

• 1 other identifier: TRD205-Ⅰ-01
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Treatment-Related Adverse Events

  The safety and tolerability of TRD205 orally administered once and/or multiple times on an empty stomach in healthy subjects

  After a single dose and/or once daily for 10 consecutive doses

Secondary Outcomes (7)

• Area under the plasma concentration versus time curve （AUC）

  After a single dose and/or once daily for 10 consecutive doses

• Peak Plasma Concentration（Cmax）

  After a single dose and/or once daily for 10 consecutive doses

• time to peak（Tmax）

  After a single dose and/or once daily for 10 consecutive doses

• Elimination rate constant（Kel）

  After a single dose and/or once daily for 10 consecutive doses

• apparent volume of distribution（Vd）

  After a single dose and/or once daily for 10 consecutive doses

Study Arms (5)

TRD205: Single ascending dose (SAD) study

EXPERIMENTAL

TRD205: oral, single ascending doses up to 7 doses levels.

Drug: TRD205

Placebo: Single ascending dose (SAD) study

PLACEBO COMPARATOR

Placebo: oral, TRD205 placebo in single ascending doses study.

Drug: Placebo

TRD205: Food effect study

EXPERIMENTAL

TRD205: oral, just 1 dose under fasted or fed condition for each period.

Drug: TRD205

Placebo: Food effect study

PLACEBO COMPARATOR

Placebo: oral, under fasted or fed condition for each period.

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.

Drug: TRD205

Interventions

TRD205 DRUG

TRD205 tablet

Multiple ascending dose (MAD) study; TRD205: Food effect study; TRD205: Single ascending dose (SAD) study

Placebo DRUG

TRD205 placebo tablet

Placebo: Food effect study; Placebo: Single ascending dose (SAD) study

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator and participant will be masked for the single ascending dose (SAD) study It's open label for multiple ascending dose (MAD) study and group B of food effect study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: August 14, 2025
• Study Start: January 26, 2024
• Primary Completion: November 27, 2024
• Study Completion: February 27, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)