Clinical Trial of Naoqingzhiming Tablets in Healthy Chinese Subjects

NCT04902534 | Unknown Phase 1 DMC

• 1 other identifier: GX-SGJG-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, double-blind, placebo-controlled, dose escalation safety, tolerability, and pharmacokinetic phase I clinical study of Naoqingzhiming Tablets in Chinese healthy subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  Maximum tolerated dose for a single dose

  500 days

• Occurrence rate of Adverse Events

  Adverse events were recorded to evaluate the safety of the studied drugs

  500 days

Secondary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  500 days

• Area under the plasma concentration versus time curve (AUC)0-t

  500 days

• Area under the plasma concentration versus time curve (AUC)0-∞

  500 days

Study Arms (2)

Naoqingzhiming Tablets

EXPERIMENTAL

Naoqingzhiming Tablets, specification:500mg(contains echinacoside 180mg) Single dose ascending. Qualified subjects will enter 6 dose groups in order from low to high: 180mg, 360mg, 720mg, 1080mg, 1620mg and 2160mg, with increasing dose design The first group (180mg) is a pre-experiment. Two subjects were selected and all received the test drug. Groups 2 to 6 received the experimental drug in 8 patients per group. Multi-dose ascending was divided into two groups: 360mg and 720mg. 10 subjects in each group received the test drug 3 times a day for 14 consecutive days.

Drug: Naoqingzhiming Tablets (contains echinacoside 180mg)

placebo (without active ingredients echinoside)

PLACEBO COMPARATOR

Placebo Tablets, specification: 500mg(without echinoside) Single dose. Groups 2 to 6 received the placebo in 2 patients per group. Multi-dose ascending. Two people in each group received placebo 3 times a day for 14 consecutive days.

Drug: placebo of Naoqingzhiming Tablets (without echinacoside)

Interventions

Naoqingzhiming Tablets (contains echinacoside 180mg) DRUG

Single dose escalation and multiple dose escalation

Naoqingzhiming Tablets

placebo of Naoqingzhiming Tablets (without echinacoside) DRUG

Single dose escalation and multiple dose escalation

placebo (without active ingredients echinoside)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects understand well trial purpose, nature, content, process and possible adverse reactions, and voluntarily sign an informed consent form.
• Healthy male or female aged between 18 and 65 years old (including the critical value).
• The body mass index is in the range of 19-26kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
• Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: physical examination, 12-lead ECG, vital sign measurements, Chest X-ray, abdominal ultrasound and laboratory safety tests .
• The subjects have no family planning within 6 months and could select contraceptive method. They have no sperm and egg donation program.
• Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
• The subjects could communicate well with researchers and complete the study according to the protocol.

You may not qualify if:

• Any history of hypersensitivity or idiosyncratic reactions to any food or drug, especially for drugs containing echinacoside.
• Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
• ALT or/and AST or/and TBIL ≤1.5 times the upper limit of normal Cr,BUN≥upper limit of normal, or Ccr≤80mL/min.
• Any history of acute or chronic illness that might affect drug absorption, and/or metabolism;
• Any history of drug abuse in the past 6 months or drug use 3 months prior to screening;
• Any history of alcohol abuse 3 months prior to screening or moderate drinkers (drink more 2 units per day or 14 units per week);
• Smoking more than 5 cigarettes per day during the 3 months prior to screening;
• Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
• Any use of other prescription drugs (including contraceptive)、over-the-counter drugs, Chinese herbal medicine, health care products and 14 days prior to medication for this study;
• Any use of prescription or over-the-counter drugs, functional vitamin, herbal/ alcohol products, grapefruit-containing or caffeine/xanthine-rich food and beverages 48 h prior to medication for this study;
• Dysphagia or having special dietary requirements;
• Occurring acute disease in the screening period or before the medication;
• Lactating or pregnant women.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Study Officials

• Yu Cao, Doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Cao, Doctor

CONTACT

+86-18661809090; caoyu1767@126.com

Pingping Lin, Doctor

CONTACT

+86-18661806517; 15111210091@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled, single dose and multiple dose escalation phase I clinical study.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: May 26, 2021
• Study Start: August 5, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 25, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)