Healthy VolunteersPhase 1NCT04902534
Clinical Trial of Naoqingzhiming Tablets in Healthy Chinese Subjects
A Phase 1 study testing Naoqingzhiming Tablets (contains echinacoside 180mg) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Naoqingzhiming Tablets (contains echinacoside 180mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2020to 25 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Yu Cao, Doctor, +86-18661809090, caoyu1767@126.com
About this study
Official title: 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
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.
Read the detailed description
The single-dose trial plan enrolls 52 Chinese healthy subjects. 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-test. Two subjects were selected and all received the test drug. They were observed for 24 hours after a single dose for safety assessment, and followed up 7-10 days after leaving the group or early withdrawal. If more than one subject has an adverse event that meets CTCAE V5.0 Grade II or above and is judged to be related to the test drug, then consider reducing the dose, otherwise proceed to the next dose group trial. Groups 2, 3, 4, 5, and 6 follow the "8+2 principle", with 10 subjects in each group, 8 receive the test drug, and 2 receive the placebo. Observe for 24 hours after a single dose for safety assessment , And follow up 7-10 days after leaving the group or early withdrawal. Each subject received only one dose group of the trial, only one study drug (experimental drug or placebo), and no longer participated in the other dose group trials or took two study drugs. During the dose escalation process, after completing the safety assessment of the previous dose group, if the dose escalation suspension standard is not met, continue the test of the lower-dose group. It is not allowed to conduct the test of 2 or more dose groups at the same time. In the above six groups of trials, it is not only necessary to observe the safety and tolerability of the subjects taking the study drug, but also to evaluate the pharmacokinetic characteristics of a single dose.
According to the results of animal pharmacokinetic studies, the dose grouping for the multiple-dose study is tentatively set to 2 groups: 360mg group and 720mg group.
The multiple-dose study plan recruited 24 Chinese healthy subjects, following the "10+2 principle", each group of 12 subjects, 10 cases received the test drug, 2 cases received placebo, 3 times a day, continuous medication On 14 days, continue to observe for 24 hours after the last administration for safety assessment, and follow up 7-10 days after leaving the group or early withdrawal. In the process of continuous medication, if 3/10 and more than 3/10 of the subjects in a dose group who received the test drug withdraw from the trial due to adverse events related to the test drug, the trial should be aborted; after completing the first group, it is safe After the sexual assessment, if the suspension criteria are not met, the second group of trials will continue. Each subject only participates in one group of trials and only receives one study drug (experimental drug or placebo), and no longer participates in other group trials or takes two study drugs. In the above two groups of trials, it is not only necessary to observe the safety and tolerability of multiple administrations, but also to evaluate the pharmacokinetic characteristics of multiple administrations.
- Conditions
- Healthy Volunteers
- Being tested
- Naoqingzhiming Tablets (contains echinacoside 180mg), placebo of Naoqingzhiming Tablets (without echinacoside)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naoqingzhiming Tablets (contains echinacoside 180mg)Drug
Single dose escalation and multiple dose escalation
placebo of Naoqingzhiming Tablets (without echinacoside)Drug
Single dose escalation and multiple dose escalation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: placebo of Naoqingzhiming Tablets (without echinacoside) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Maximum tolerated dose for a single dose
Measured: 500 days
Occurrence rate of Adverse Events
Adverse events were recorded to evaluate the safety of the studied drugs
Measured: 500 days
Secondary outcomes (3)
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 500 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Measured: 500 days
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Measured: 500 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start5 Aug 2020
- Primary completion30 May 2021 (estimated)
- Study completion25 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A randomized, double-blind, placebo-controlled, single dose and multiple dose escalation phase I clinical study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Doctor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902534
- Sponsor's protocol ID
- GX-SGJG-001
- Status last verified
- May 2021
- First submitted
- 23 Sep 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the technical achievements and outcomes of this trial are owned by Beijing Sili'an Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04902534
- Acronym / sponsor ID
- GX-SGJG-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 25 Jun 2021 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The single-dose trial plan enrolls 52 Chinese healthy subjects. 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-test. Two subjects were selected and all received the test drug. They were observed for 24 hours after a single dose for safety assessment, and followed up 7-10 days after leaving the group or early withdrawal. If more than one subject has an adverse event that meets CTCAE V5.0 Grade II or above and is judged to be related to the test drug, then consider reducing the dose, otherwise proceed to the next dose group trial. Groups 2, 3, 4, 5, and 6 follow the "8+2 principle", with 10 subjects in each group, 8 receive the test drug, and 2 receive the placebo. Observe for 24 hours after a single dose for safety assessment , And follow up 7-10 days after leaving the group or early withdrawal. Each subject received only one dose group of the trial, only one study drug (experimental drug or placebo), and no longer participated in the other dose group trials or took two study drugs. During the dose escalation process, after completing the safety assessment of the previous dose group, if the dose escalation suspension standard is not met, continue the test of the lower-dose group. It is not allowed to conduct the test of 2 or more dose groups at the same time. In the above six groups of trials, it is not only necessary to observe the safety and tolerability of the subjects taking the study drug, but also to evaluate the pharmacokinetic characteristics of a single dose.
According to the results of animal pharmacokinetic studies, the dose grouping for the multiple-dose study is tentatively set to 2 groups: 360mg group and 720mg group.
The multiple-dose study plan recruited 24 Chinese healthy subjects, following the "10+2 principle", each group of 12 subjects, 10 cases received the test drug, 2 cases received placebo, 3 times a day, continuous medication On 14 days, continue to observe for 24 hours after the last administration for safety assessment, and follow up 7-10 days after leaving the group or early withdrawal. In the process of continuous medication, if 3/10 and more than 3/10 of the subjects in a dose group who received the test drug withdraw from the trial due to adverse events related to the test drug, the trial should be aborted; after completing the first group, it is safe After the sexual assessment, if the suspension criteria are not met, the second group of trials will continue. Each subject only participates in one group of trials and only receives one study drug (experimental drug or placebo), and no longer participates in other group trials or takes two study drugs. In the above two groups of trials, it is not only necessary to observe the safety and tolerability of multiple administrations, but also to evaluate the pharmacokinetic characteristics of multiple administrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled, single dose and multiple dose escalation phase I clinical study.
| Arm | Type | Receives |
|---|---|---|
| Naoqingzhiming Tablets | Experimental | Drug: Naoqingzhiming Tablets (contains echinacoside 180mg)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. |
| placebo (without active ingredients echinoside) | Placebo comparator | Drug: placebo of Naoqingzhiming Tablets (without echinacoside)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naoqingzhiming Tablets (contains echinacoside 180mg)Single dose escalation and multiple dose escalation | Drug | Naoqingzhiming Tablets |
| placebo of Naoqingzhiming Tablets (without echinacoside)Single dose escalation and multiple dose escalation | Drug | placebo (without active ingredients echinoside) |
Primary outcome
Maximum tolerated dose
Time frame: 500 days
Maximum tolerated dose for a single dose
Occurrence rate of Adverse Events
Time frame: 500 days
Adverse events were recorded to evaluate the safety of the studied drugs
3 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 500 days
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 500 days
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 500 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No. All the technical achievements and outcomes of this trial are owned by Beijing Sili'an Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Cao, Doctor principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naoqingzhiming Tablets (contains echinacoside 180mg) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, Doctor (+86-18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: 500 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.