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Healthy Elderly SubjectsPhase 1NCT04197661

Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

A Phase 1 study testing HSK3486 in people with Healthy Elderly Subjects, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Elderly Subjects
What is being tested?
HSK3486
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
25 Dec 2019to 22 May 2020
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form and fully understand the content, procedure and possible adverse effects before the trial starts;
  • Able to complete the study in compliance with the requirements of the clinical trial protocol;
  • Subjects (including their partners) are willing to voluntarily adopt an effective measure of contraception starting from screening to 6 months after the last dose of the investigational drug. See the attachment for specific contraceptive measures;
  • Males and females with full capacity for civil conduct, aged ≥ 18 years old (aged between 18 and 64 years old for the non-elderly group and ≥ 65 years old for the elderly group (inclusive));
  • Females weighing ≥ 45 kg and males weighing ≥ 50 kg, and with a body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 (BMI = Weight (kg)/height2(m2))(inclusive);
  • For all subjects, the body temperature should be between 35.9-37.6 °C, respiratory rate between 12-20 breaths/min, and SpO2 when inhaling > 95%; in addition, for subjects in the non-elderly group, the blood pressure should be between 90-140/60-90 mmHg and heart rate between 60-99 bpm; for those in the elderly group, the blood pressure should be between 90-160/60-100 mmHg and heart rate between 50-100 bpm;

Who cannot join

  • Smoke more than 5 cigarettes per day on average within 3 months prior to screening;
  • Patient having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
  • Known sensitivity to HSK3486 excipients (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); or history of drug allergies (including other anesthetics), allergic diseases, or those with hyperactive immuneresponse(allergies to various drugs and foods);
  • History of drug abuse or any signs of long-term use of benzodiazepines (such as insomnia, anxiety, spasms) within 3 months prior to screening;
  • Acute diseases with clinical significance (determined by the investigator) within 2 weeks prior to screening, including GI diseases and infections (such as respiratory or CNS infections);
  • History or evidence of cardiovascular diseases prior to screening: Uncontrolled hypertension [SBP ≥ 170 mmHg and/or DBP ≥ 105 mmHg without antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥ 450 ms (Fridericia's correction formula);
  • Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Phase I Clinical Trial Laboratory, The First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Study Evaluating Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Healthy Elderly Subjects

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.

Being tested
HSK3486
Keywords
Healthy Elderly Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK3486Drug

    Also called HSK3486 0.2 mg/kg

    Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

  • HSK3486Drug

    Also called HSK3486 0.3 mg/kg

    Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

  • HSK3486Drug

    Also called HSK3486 0.4 mg/kg

    Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

  • HSK3486Drug

    Also called HSK3486 0.4 mg/kg

    Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

Study groups in NCT04197661
Study groupRoleWhat they receive
Elderly groupⅠActive comparatorElderly groupⅠ 65 years or older 0.2 mg/kg HSK3486
Receives: Drug: HSK3486
Elderly group ⅡActive comparatorElderly group Ⅱ 65 years or older 0.3 mg/kg HSK3486
Receives: Drug: HSK3486
Elderly group ⅢActive comparatorElderly group Ⅲ 65 years or older 0.4 mg/kg HSK3486
Receives: Drug: HSK3486
Non-elderly group IVActive comparatorNon-elderly group IV 18 to 64 years 0.4 mg/kg HSK3486
Receives: Drug: HSK3486

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak concentration (Cmax)

    Cmax（a measure of the body's exposure to HSK3486）will be compared between non-elderly subjects and elderly subjects.

    Measured: -30 minutes before administration until 24 hours post administration on day 1

  2. Area under the concentration-time curve（AUC）

    AUC（a measure of the body's exposure to HSK3486）will be compared between non-elderly subjects and elderly subjects.

    Measured: -30 minutes before administration until 24 hours post administration on day 1

Secondary outcomes (5)

  1. MOAA/S(modified observer's assessment of alert /sedation)

    modified observer's assessment of alert /sedation

    Measured: -5 minutes before administration until 1 hours post administration on day 1

  2. Bispectral index(BIS)

    Bispectral index

    Measured: -5 minutes before administration until 1 hours post administration on day 1

  3. Tmax

    time to peak observed

    Measured: -30 minutes before administration until 24 hours post administration on day 1

  4. Total clearance

    Total clearance

    Measured: -30 minutes before administration until 24 hours post administration on day 1

  5. blood pressure（systolic, diastolic and mean arterial pressure）

    safety endpoits

    Measured: from the screening to 2 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start25 Dec 2019
  3. Primary completion22 Jan 2020
  4. Study completion22 May 2020

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197661
Sponsor's protocol ID
HSK3486-108
Status last verified
Dec 2020
First submitted
6 Dec 2019
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.

    PubMed 28430430

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK3486 in people with Healthy Elderly Subjects, run by Sichuan Haisco Pharmaceutical Group 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 6 inclusion and 7 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 17 Dec 2020. 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?

Peak concentration (Cmax) (time frame: -30 minutes before administration until 24 hours post administration on day 1). 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?

On the ClinicalTrials.gov record for NCT04197661, which also lists 1 linked publication.

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 17 Dec 2020.

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