First-in-Human Study to Investigate the Safety and Tolerability and Pharmacokinetics of HS-10383

NCT05429723 | Unknown Phase 1

• 1 other identifier: HS-10383-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of HS-10383 using a randomized, double blind, placebo controlled, single center study design. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be one single dose of study drug/placebo received on only one day. The total study duration for each participant will be usually no more than 10 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Conditions

Cough

Keywords

RUCC, P2X3

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability Evaluation

  1. Adverse events (AEs), serious adverse events (SAEs) and adverse events leading to withdrawal from the study, the incidence, severity and correlation with the trial drug; 2. Changes in laboratory tests (blood routine, urine routine, blood biochemistry and coagulation function) before and after administration; 3. Changes in vital signs (respiration, pulse, blood pressure and body temperature) and SpO2 before and after administration; 4. Electrocardiogram (ECG) to check the changes before and after administration.

  up to 9 days

Secondary Outcomes (9)

• Maximum plasma concentration (Cmax)

  up to 9 days

• Time of Maximum Concentration

  up to 9 days

• Terminal Rate Constant

  up to 9 days

• Elimination Halflife

  up to 9 days

• Area Under the Concentration-time Curve0-t

  up to 9 days

Study Arms (2)

HS-10383

EXPERIMENTAL

HS-10383 was administered at 8 am on the first day, 4 dose levels

Drug: HS-10383

HS-10383 Placebo

PLACEBO COMPARATOR

Matching placebo to HS-10383 was administered at 8 am on the first day, 4 dose levels

Drug: HS-10383 Placebo

Interventions

HS-10383 DRUG

HS-10383 administered as one 50 mg, 150 mg, 450 mg and 900 mg tablet once daily, depending upon randomization.

HS-10383

HS-10383 Placebo DRUG

Placebo for HS-10383

HS-10383 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 sign the informed consent;
• Male weight ≥ 50kg, female weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18\~26 (including the critical value);
• Subjects need to agree to take effective contraceptive methods from the screening date to 90 days after the last dose;
• Male subjects must agree not to donate sperm within 90 days from the start of the administration to the last administration.

You may not qualify if:

• The following medical histories, such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system and tumor, etc., were screened. evaluated as unsuitable to participate in this study;
• Any known presence or history of hypogeusia, abnormal taste or dysgeusia;
• Any known presence or history of severe allergies, or known to be allergic to the components of the test drug;
• Use of any drugs, including prescription drugs, over-the-counter drugs or herbal preparations, cannot be avoided or expected to start 2 weeks (or 5 half-lives) before screening and throughout the study period;
• Any findings of electrocardiogram outside from normal, such as the QT interval (QTcF) corrected by the Fridericia formula, the absolute value of QTcF for males is \>450 ms, and the absolute value of QTcF for females is \>470 ms;
• Any findings of blood pressure or pulse in resting state outside from normal a: such as systolic blood pressure \<90 mmHg or ≥140 mmHg, diastolic blood pressure \<60 mmHg or ≥90 mmHg, pulse \<55 bpm or \>100 bpm;
• Serum creatinine exceeds the upper limit of normal (ULN) at screening;
• Infectious diseases with hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody test were positive at the time of screening;
• Any findings from the medical examination (comprehensive physical examination, vital signs, blood oxygen saturation, laboratory tests, abdominal B-ultrasound and chest X-ray ) outside from normal and deemed by the investigator to be clinically significant;
• Drug abusers, or have used soft drugs (such as marijuana) within 3 months prior to screening, or have taken hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before screening;
• Volunteers who with a positive alcohol breath test at screening, with a history of alcohol abuse or a single consumption of more than 14 units of alcohol in the past two weeks (1 unit = 285 mL of beer, 25 mL of spirits, and 150 mL of wine);
• Smokers or those who smoked more than 5 cigarettes per day within 3 months prior to screening, or those who could not stop using any tobacco products (including e-cigarettes) during the study;
• Average daily intake of coffee or tea ≥ 5 cups (200mL/cup) within 3 months prior to screening;
• Volunteers who donated or lost 250 mL more of blood in 3 months prior to screening, or had undergone major surgery in the past;
• Volunteers who participated in any clinical trials and took any clinical trial drugs within 3 months prior to screening;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong provincial qianfoshan hospital

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Zhao, Doctor

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Doctor

CONTACT

15131190710; zhao4wei2@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 23, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (1)