Phase 1a Study in Healthy Participants

NCT05953506 | Unknown Phase 1

• 1 other identifier: HS-10506-101
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.

Conditions

Healthy

Keywords

HS-10506, Phase 1, Healthy

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug

  The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.

  Screening until Trail phase (up to 5 weeks)

• Number of participants with clinically significant change from baseline in vital signs

  From baseline to Day 3

• Number of participants with clinically significant abnormalities in physical examination

  From baseline to Day 3

• Changes in 12-lead electrocardiogram from before to after dosing

  Descriptive statistics of heart rate, PR interval, QT interval, and QTcF for observed values and changes from baseline will be summarized at each scheduled time point.

  From baseline to Day 3

• Change in Stanford Sleepiness Scale score from before to after dosing

  Stanford Sleepiness Scale（SSS） is a simple and accurate method used to assess sleepiness symptom. Respondents use the scale from 1 to 7 to indicate their current level of sleepiness. Higher scores mean a higher level of sleepiness. Descriptive statistics of SSS scores and changes from baseline will be summarized at each scheduled time point.

  From baseline to 4 hours after dosing

Secondary Outcomes (9)

• Observed maximum plasma concentration (Cmax)

  up to 48 hours after dosing

• Time to reach maximum plasma concentration (Tmax)

  up to 48 hours after dosing

• Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）

  up to 48 hours after dosing

• Area under the concentration-time curve from time zero to infinity（AUC0-∞）

  up to 48 hours after dosing

• Terminal Rate Constant（λz）

  up to 48 hours after dosing

Study Arms (2)

HS-10506

EXPERIMENTAL

Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1.

Drug: HS-10506

HS-10506 Placebo

EXPERIMENTAL

Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1.

Drug: HS-10506 Placebo

Interventions

HS-10506 DRUG

HS-10506 will be administered orally once on Day 1.

HS-10506

HS-10506 Placebo DRUG

Matching placebo will be administered orally once on Day 1.

HS-10506 Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged from 18 to 45 years
• Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
• Males' weight ≥ 50kg, females' weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18\~28 (including the critical value)
• During the study and for 3 months after receiving the last dose of study drug, subjects must agree not to donate sperm or eggs, not to plan to have children, and to use an effective method of contraception

You may not qualify if:

• Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
• Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4 or CYP3A5, within 2 weeks (or 5 half-lives) before screening and throughout the study period
• Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), \>450 ms (males), \>470 ms (females)
• Has current manifestation of blood pressure or pulse abnormalities in resting state: such as systolic blood pressure \<90 mmHg or ≥140 mmHg, diastolic blood pressure \<60 mmHg or ≥90 mmHg, pulse \<55 bpm or \>100 bpm

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Huafang Li

CONTACT

021-34773128; lhlh_5@163.com

Study Design

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

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 20, 2023
• Study Start: July 17, 2023
• Primary Completion: December 24, 2023
• Study Completion: December 24, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07