A Study of SYHA1805 in Healthy Subjects

NCT04977570 | Unknown Phase 1

• 1 other identifier: HA1806-CSP-002
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose of SYHA1805.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of multiple-dose of SYHA1805

  The safety and tolerability of multiple-dose of SYHA1805 administered orally will be assessed by incidence and severity of adverse events (AEs), ECG, changes in vital signs, physical Examination, and laboratory examinations.

  Baseline through Day 28

Secondary Outcomes (5)

• Area under the plasma concentration versus time curve (AUC）

  Baseline through Day 28

• Peak Plasma Concentration (Cmax）

  Baseline through Day 28

• Time to maximum plasma concentration（Tmax）

  Baseline through Day 28

• Half time (t1/2)

  Baseline through Day 28

• Apparent clearance (CL/F)

  Baseline through Day 28

Study Arms (2)

SYHA1805

EXPERIMENTAL

subjects will be randomized to receive multiple ascending doses of SYHA1805 tablets.

Drug: SYHA1805 tablets

Placebo

PLACEBO COMPARATOR

subjects will be randomized to receive the matching placebo tablets.

Drug: Placebo

Interventions

SYHA1805 tablets DRUG

Oral tablets of SYHA1805 with three pre-designed doses

SYHA1805

Placebo DRUG

Oral tablets of placebo with matching doses

Placebo

Eligibility Criteria

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

You may qualify if:

• Age: 18 to 45 years of age inclusive;
• Weight: Body weight ≥50 kg, body mass index (BMI) within the range of 19-28 kg/m2 (inclusive), BMI = weight (kg) / height 2 (m2);
• Overtly healthy as determined by medical evaluation including comprehensive physical examinations, vital signs, laboratory examinations, ECG examination, color Doppler ultrasound (abdominal color Doppler ultrasound, heart color Doppler ultrasound), chest X-ray, etc.;
• Agree to use highly effective contraceptive methods (such as condoms or intrauterine devices, contraceptive drugs) during the clinical trial period (screening period to 30 days after the last dose). Male subject refrains from sperm donation;
• Fully understand the content and possible adverse reactions of the test drug, have the ability to communicate with investigators normally, and able to comply with the research requirements (such as: visit on time, and follow the procedures, restrictions and requirements of the protocol);
• Volunteer to participate in the study and sign the informed consent form.

You may not qualify if:

• Have history or other underlying risk factors of torsade de pointes ventricular tachycardia, short QT syndrome, long QT syndrome. Have first-degree relatives (biological parents, siblings or children) who suffered from sudden death in young age (less than/equal to 40 years old), drowning or sudden infant death syndrome of unknown cause;
• Have history of malignant tumors, mental illness, depression, anxiety, and epilepsy;
• Have history of drugs abuse in the past 3 years, or positive drug test at screening;
• Have history of clinically significant drug allergies, or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis), or those who are known to be allergic to experimental drug excipients or the same type of drugs;
• The investigator determines that the subjects have disease that affect drug absorption, distribution, metabolism, or excretion, such as:
• History of inflammatory bowel disease, gastritis, ulcers, bile duct stones, gastrointestinal or rectal bleeding;
• History of major gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, or bowel resection);
• History or clinical evidence of pancreatic injury or pancreatitis;
• ALT, AST, or total serum bilirubin greater than 2 times the upper limits of normal (ULN) or other liver function test abnormalities during the screening period or the baseline period, and the abnormalities are determined by the investigator to have clinical significance, suggesting liver disease or liver damage;
• Renal function suggests that the creatinine clearance rate is less than 90 mL/min, or has urinary tract obstruction or difficulty in emptying urine during the screening period or the baseline period;
• HBsAg positive, HCV-Ab positive, HIV-Ab positive or syphilis antibody positive during the screening period;
• Have history of alcohol abuse within 6 months before screening, have a positive alcohol breath test during the screening period and the baseline period, or cannot stop drinking during the entire study period; Subjects smoke more than 5 cigarettes per day within the 3 months prior to screening, have a positive nicotine test at screening, or cannot give up smoking during the entire study period;
• Have participated in clinical trials of any drug or medical device within 3 months before screening;
• Have undergone major surgery within 3 months before screening, or have had severe infections within 4 weeks before screening;
• Have had significant change in diet or exercise habits within 3 months before screening, such as weight loss, diet, exercise, etc.;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Officials

• Kun Lou, master

  CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Chanjuan Wang

CONTACT

15226599687; wangchanjuan@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 27, 2021
• Study Start: July 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share