Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

NCT ID: NCT04197661

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-25
• Study Completion Date: 2020-05-22

Brief 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.

Conditions

Healthy Elderly Subjects

Keywords

Healthy Elderly Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Elderly groupⅠ

Elderly groupⅠ 65 years or older 0.2 mg/kg HSK3486

Group Type: ACTIVE_COMPARATOR

HSK3486

Intervention Type: DRUG

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

Elderly group Ⅱ

Elderly group Ⅱ 65 years or older 0.3 mg/kg HSK3486

Group Type: ACTIVE_COMPARATOR

HSK3486

Intervention Type: DRUG

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

Elderly group Ⅲ

Elderly group Ⅲ 65 years or older 0.4 mg/kg HSK3486

Group Type: ACTIVE_COMPARATOR

HSK3486

Intervention Type: DRUG

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

Non-elderly group IV

Non-elderly group IV 18 to 64 years 0.4 mg/kg HSK3486

Group Type: ACTIVE_COMPARATOR

HSK3486

Intervention Type: DRUG

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

Interventions

HSK3486

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

Intervention Type: DRUG

HSK3486

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

Intervention Type: DRUG

HSK3486

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

Intervention Type: DRUG

HSK3486

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

Intervention Type: DRUG

Other Intervention Names

HSK3486 0.2 mg/kg; HSK3486 0.3 mg/kg; HSK3486 0.4 mg/kg; HSK3486 0.4 mg/kg

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form and fully understand the content, procedure and possible adverse effects before the trial starts;

2. Able to complete the study in compliance with the requirements of the clinical trial protocol;

3. 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;

4. 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));

5. 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);

6. 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;

Exclusion Criteria

1. Smoke more than 5 cigarettes per day on average within 3 months prior to screening;

2. Patient having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;

3. 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);

4. History of drug abuse or any signs of long-term use of benzodiazepines (such as insomnia, anxiety, spasms) within 3 months prior to screening;

5. 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);

6. 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);

7. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Changchun, Jilin, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 28430430 (View on PubMed)

Other Identifiers

HSK3486-108

Identifier Type: -

Identifier Source: org_study_id