Healthy Elderly SubjectsPhase 1NCT06764147
Safety and Pharmacokinetics/ Pharmacodynamics of Methoxyethyl Etomidate Hydrochloride in Healthy Elderly Subjects
A Phase 1 study testing ET-26HCl in people with Healthy Elderly Subjects, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Subjects
- What is being tested?
- ET-26HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 2 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adult male and female subjects aged ≥18 years;
- Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- Blood pressure of healthy subjects should be between 90-139/60-89 mmHg, heart rate and pulse should be between 55-100 beats/min
- The subjects had good communication with the investigators, signed the informed consent form voluntarily, and were able to complete the trial according to the protocol.
Who cannot join
- -
- Auxiliary examination:
- If the results of physical examination, vital signs, color Doppler echocardiography (only for healthy elderly subjects), cortisol test, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine) and 12-lead electrocardiogram were abnormal and clinically significant by investigator evaluation;
- potentially difficult airway (modified Mallampati score III-IV);
- hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- Medication history:
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- use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
- use of any prescribed medication within 14 days before dosing;
- use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration;
- History of disease and surgery:
- have a history of any clinically serious diseases or diseases or conditions considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immune, psychiatric, or metabolic diseases;
- patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
- patients who underwent any surgery within 6 months before screening;
- Allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
- Living habits:
- binge drinking or regular drinking in the 6 months before screening, i.e. more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test at baseline;
- if they smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study;
- with drug abuse or drug abuse history in the past three months; Or the baseline urine drug test was positive;
- habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial;
- Others:
- those who have difficulty in blood collection, can not tolerate venipuncture, and can not tolerate arterial blood collection (e.g. Allen's test positive);
- participated in any other clinical trial (including drug and device clinical trial) within 3 months before screening;
- vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
- pregnant or lactating women;
- those who planned to give birth or donate sperm during the trial and half a year after the completion of the trial, or those who did not agree that the subjects and their spouses should take strict contraceptive measures during the trial and half a year after the completion of the trial;
- had blood loss or donation >400 mL within 3 months before screening, or received blood transfusion within 1 month;
- subjects with any factors considered by the investigator to be ineligible for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, 250014
About this study
Official title: Phase 1 Pharmacokinetic Study of Methoxyethyl Etomidate Hydrochloride for Injection With a Single Dose in Elderly Subjects
16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg.
All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.
- Conditions
- Healthy Elderly Subjects
- Being tested
- ET-26HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET-26HClDrug
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.
| Study group | Role | What they receive |
|---|---|---|
| Non-elderly group | Experimental | aged 18-64 years (including boundary value) Receives: Drug: ET-26HCl |
| Elderly group | Experimental | aged ≥65 years old, of which no less than 3 cases were ≥75 years old Receives: Drug: ET-26HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Cmax
Measured: up to 24 hours after infusion
Pharmacokinetic parameters
Tmax
Measured: up to 6 hours after infusion
Pharmacokinetic parameters
T1/2
Measured: up to 12 hours after infusion
Pharmacokinetic parameters
AUC0-t
Measured: immediately after infusion to 24 hours after infusion
Secondary outcomes (3)
Pharmacodynamic indicators
modified observer's assessment of alert（MOAA/S） score: The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness
Measured: MOAA/S score was measured within 60 minutes before administration, was performed every 1 minute±5second within 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration
Pharmacodynamic indicators
bispectral index: BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition.
Measured: BIS score was measured within 60 minutes before administration as baseline value,was performed every 1 minute±5second within 5minutes of administration and every 2minutes±30seconds after 5minutes of administration
Pharmacodynamic indicators：Eyelash reflex
When the anesthesiologist touches the eyelashes with the anterior fibers of the cotton swab, it can cause the blink of the examined person, that is, there is an eyelash reflex. If the reaction disappears, the depth of anesthesia is judged to reach the degree of loss of consciousness
Measured: every 1 minute± 5seconds during the first 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start25 Dec 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly SubjectsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Pharmaciae Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764147
- Sponsor's protocol ID
- ET-26-HCL-CP-005
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Pharmacokinetic Study of Methoxyethyl Etomidate Hydrochloride for Injection With a Single Dose in Elderly Subjects
- ClinicalTrials.gov ID
- NCT06764147
- Acronym / sponsor ID
- ET-26-HCL-CP-005
- Conditions
- Healthy Elderly Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 8 Jan 2025 (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.
16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg.
All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-elderly group | Experimental | Drug: ET-26HClaged 18-64 years (including boundary value) |
| Elderly group | Experimental | Drug: ET-26HClaged ≥65 years old, of which no less than 3 cases were ≥75 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy adult male and female subjects aged ≥18 years;
- Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- Blood pressure of healthy subjects should be between 90-139/60-89 mmHg, heart rate and pulse should be between 55-100 beats/min
- The subjects had good communication with the investigators, signed the informed consent form voluntarily, and were able to complete the trial according to the protocol.
Key exclusion criteria (27 listed)
- -
- If the results of physical examination, vital signs, color Doppler echocardiography (only for healthy elderly subjects), cortisol test, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine) and 12-lead electrocardiogram were abnormal and clinically significant by investigator evaluation;
- potentially difficult airway (modified Mallampati score III-IV);
- hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before 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 |
|---|---|---|
| ET-26HClThe dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s. | Drug | Elderly group, Non-elderly group |
Primary outcome
Pharmacokinetic parameters
Time frame: up to 24 hours after infusion
Cmax
Pharmacokinetic parameters
Time frame: up to 6 hours after infusion
Tmax
Pharmacokinetic parameters
Time frame: up to 12 hours after infusion
T1/2
Pharmacokinetic parameters
Time frame: immediately after infusion to 24 hours after infusion
AUC0-t
3 secondary outcomes
Pharmacodynamic indicators
Time frame: MOAA/S score was measured within 60 minutes before administration, was performed every 1 minute±5second within 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration
Pharmacodynamic indicators
Time frame: BIS score was measured within 60 minutes before administration as baseline value,was performed every 1 minute±5second within 5minutes of administration and every 2minutes±30seconds after 5minutes of administration
Pharmacodynamic indicators：Eyelash reflex
Time frame: every 1 minute± 5seconds during the first 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Healthy Subjects (HS)
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.
Wei Zhao, Pharmaciae Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
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 ET-26HCl in people with Healthy Elderly Subjects, run by Ahon Pharmaceutical Co., Ltd. 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 4 inclusion and 27 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: finished, as of the sponsor's last update on 24 Jan 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (time frame: up to 24 hours after infusion). The study lists 4 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 24 Jan 2025.