NCT05504746

A Phase I Study of SHEN26 Capsule in Healthy Participants

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SHEN26 Capsule in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd. · Network
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, and placebo-controlled phase I clinical trial. It is designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules after single and multiple ascending dosing in healthy Chinese adult participants, and the food effect on the PK profile of SHEN26 capsules.

Detailed description

This phase of the study includes three parts: single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) in healthy participants. * SAD Part: There are dose groups of 50 mg, 200 mg, 400 mg, 800 mg, and 1200 mg for the SAD part of the trial. * FE Part: This part of the study is tentatively assigned to the 400 mg dose group of the SAD part. After the participants complete the SAD part and pass their safety check on Day 4, they enter the second cycle. Participants are required to fast for more than 10 hours on the night of Day 4, and they will be dosed again on Day 5, 30 min after the start of the high-fat meal (the meal had to be completed within 30 min). * MAD Part: Based on the safety, tolerability, and PK data from the SAD part, if available, the appropriate dose will be selected for the MAD study. Three dose groups of 200 mg, 400 mg, and 600 mg are planned for this part of the study.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	SHEN26 capsule	Specification: 50mg/capsule and 200mg/capsule. Participants will receive SHEN26 capsule(s) orally for a single dose. The specification of 50mg/capsule will only be used for the 50mg dose group in the SAD part. For the other dose groups and other parts of the study, 200mg/capsule will be used.
DRUG	SHEN26 capsule	Specification: 200mg/capsule. Participants will receive SHEN26 capsules orally for Q12h X 5.5 days.
DRUG	SHEN26 placebo	Placebo matching the SHEN26 capsule. Specification: 50mg/capsule and 200mg/capsule. Participants will receive SHEN26 placebo orally for a single dose.
DRUG	SHEN26 placebo	Placebo matching the SHEN26 capsule. Specification: 200mg/capsule. Participants will receive SHEN26 placebo orally for Q12h X 5.5 days.

Timeline

• Start date: 2022-08-08
• Primary completion: 2022-12-11
• Completion: 2022-12-11
• First posted: 2022-08-17
• Last updated: 2022-12-16

Locations

1 site across 1 country: China