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Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers

NCT04161547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-28

No results posted yet for this study

Summary

A randomized, single-center, double-blind, ascending multiple-dose, placebo-controlled study to evaluate the tolerability and pharmacokinetics of CSPCHA115 capsules in Chinese healthy volunteers.

Conditions

  • Asthma; Allergic Rhinitis

Interventions

DRUG

CSPCHA115 100 mg; Matching placebo 100 mg

CSPCHA115 100 mg once daily in the fasted state for 7 days; Matching placebo 100 mg once daily in the fasted state for 7 days.

DRUG

CSPCHA115 200 mg; Matching placebo 200 mg

CSPCHA115 200 mg once daily in the fasted state for 7 days; Matching placebo 200 mg once daily in the fasted state for 7 days.

DRUG

CSPCHA115 400 mg; Matching placebo 400 mg

CSPCHA115 400 mg once daily in the fasted state for 7 days; Matching placebo 400 mg once daily in the fasted state for 7 days.

DRUG

CSPCHA115 600 mg; Matching placebo 600 mg

CSPCHA115 600 mg once daily in the fasted state for 7 days; Matching placebo 600 mg once daily in the fasted state for 7 days.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xuefang Xia · Department of Medicine, CSPC Clinical Development Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2020-06-01
Completion
2020-06-01

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 NCT04161547 on ClinicalTrials.gov