Study of Aolanti Weikang Tablets in Healthy Volunteers

A Single-center, Randomized, Doule Blind, Placebo-controlled, Multiple Dose Escalation Phase 1b Study to Evaluate the Safety and Tolerability of Aolanti Weikang Tablets in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Other: Placebo; Drug: Aolanti Weikang tablets

Detailed Description

This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Xiyuan Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index (BMI) :≥19 and ≤26 kg/m2
• Signed written informed consent

Exclusion Criteria:

• With in 7 days of Screening, the average number of stool > 2 times/day
• With in 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale
• At least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others)
• Digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator
• Smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration
• History of drug or aurantium allergy
• Concomitant medication within 2 weeks prior to drug administration or any drug being used
• Participated in other clinical trials within 3 months before Screening
• Major surgery/surgical therapy for any cause within 4 weeks of Screening, or scheduled surgeries within 2 weeks after the last dose of study drug
• Subjects not agree to use adequate contraception from study entry through at least 28 days after the last dose of study drug
• Pregnancy or nursing
• Other conditions that unsuitable for enrollment considered by Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aolanti Weikang tablets; 3，6 or 8 Aolanti Weikang tablets each time,tid	Drug: Aolanti Weikang tablets; Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).
Placebo Comparator: Placebo; 3,6 or 8 tablets each time,tid	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets	Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and grade of treatment-related adverse events (AEs)	All of the AE are assessed by NCI-CTCAE v4.03	3 weeks

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Xudong Tang, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): April 21, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: QF-WKP-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No