A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants

NCT06673927 | Completed Phase 1

• 1 other identifier: YZJ-1139-1-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective：

1. 1.To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants
2. 2.To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 to Day 3 post single dose；From Day 1 to Day 14 post multiple dose；

Secondary Outcomes (11)

• Cmax of YZJ-1139

  From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose

• AUCinf of YZJ-1139

  From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose

• AUClast of YZJ-1139

  From Day 1 to Day 2 post single dose；From Day 1 to Day 8 post multiple dose

• AUC0-τ of YZJ-1139

  From Day 1 to Day 8 post multiple dose

• Css,avg of YZJ-1139

  From Day 1 to Day 8 post multiple dose

Study Arms (2)

YZJ-1139 Single-dose Group

EXPERIMENTAL

Subjects will be randomized into two groups： the experimental group will receive YZJ-1139; the control group will receive placebo.

Drug: YZJ-1139

YZJ-1139 multiple-dose Group

EXPERIMENTAL

Subjects will be randomized into two groups；the experimental group will receive YZJ-1139; the control group will receive placebo once a day, 7 days.

Drug: YZJ-1139; Drug: Placebo

Interventions

YZJ-1139 DRUG

Single oral dose, 2mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg

YZJ-1139 Single-dose Group

Placebo DRUG

Placebo administration

YZJ-1139 multiple-dose Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects, with the proportion of a single gender in each group not less than 1/3;
• Aged between 18 and 45 years (inclusive of 18 and 45 years);
• The body mass index (BMI) ranges from 19 to 24 (inclusive of 19 and 24), where BMI = weight (kg) / height squared (m²). At the time of entering the study, the weight of female volunteers must be no less than 50 kg, and that of male volunteers must be no less than 55 kg;
• Those who pass comprehensive physical examinations (vital signs, height, weight, and chest and abdominal examinations, etc.) and laboratory tests (blood routine, blood biochemistry, urine routine, electrocardiogram, infectious disease screening, etc.), and have no abnormalities or only minor abnormalities without clinical significance in 12-lead electrocardiogram, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), anteroposterior and lateral chest radiographs, etc.;
• Volunteers who can comprehend the procedures and methods of this study, are willing to strictly adhere to the clinical trial protocol to complete the trial, and sign the informed consent form.

You may not qualify if:

• After researchers determine that the subject has a disease that affects drug absorption, distribution, metabolism, and excretion or may reduce compliance (cardiovascular, liver, kidney, gastrointestinal, immune, hematological, endocrine, metabolic, cancer, psychiatric and neurological conditions);
• A history of specific allergic reactions (such as asthma, eczema, allergic dermatitis); known allergies to the trial drug and its excipient components; a history of drug allergies;
• A history of obstructive sleep apnea or chronic obstructive pulmonary disease;
• A history of severe unconscious hypoglycemia;
• A history of stroke, chronic epilepsy, or neurological disorders;
• A history of diminished memory or abnormal behavior;
• A history of drug dependence within the past 2 years (smoking excluded), seizure disorders, syncope history;
• A clinically significant illness within the past month before enrollment, especially severe infections, trauma, or major surgery;
• The use of any prescription drugs or herbal medicines within the past month before enrollment, and non-prescription drugs or food supplements within the past 2 weeks;
• Regular use of sedatives, sleeping pills, or other addictive drugs, and positive urine drug screening;
• had donated blood within the 3 months prior to the study, or had severe blood loss equivalent to at least 500 mL of blood loss;
• Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, syphilis antibody positive;
• Have a history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or about 100 ml of wine) and test positive for alcohol;
• Smokers who smoked more than 5 or equivalent cigarettes per day in the 3 months before the test and those who tested positive for nicotine should not give up smoking during the test;
• Drinking excessive tea and coffee drinks (more than 8 cups) per day;

Sponsors & Collaborators

• Shanghai Haiyan Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Ditan Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

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

Model Details: Dose escalation

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2017
• Primary Completion: November 21, 2018
• Study Completion: March 8, 2019
• Last Updated: February 10, 2025

Record last verified: 2024-11

Locations

CN (1)