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A Phase I Study of SHEN26 Capsule in Healthy Participants

NCT05504746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-12-16

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

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.

Sponsors & Collaborators

  • Shenzhen Kexing Pharmaceutical Co., Ltd.

    lead NETWORK

Principal Investigators

  • Hui Zhao, MMed · The Second Hospital of Anhui Medical University

  • Wei Hu, MD · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2022-12-11
Completion
2022-12-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504746 on ClinicalTrials.gov