NCT07394452

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Hangzhou PhecdaMed Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	TJ0113 Capsules	Participants will receive oral administration of TJ0113.
OTHER	Placebo	Participants will receive oral administration of Placebo.

Timeline

• Start date: 2023-08-04
• Primary completion: 2024-02-05
• Completion: 2024-04-03
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China