A Study of SYHA1805 in Healthy Adult Subjects

NCT04645901 | Unknown Phase 1 DMC

• 1 other identifier: SYHA1805-CSP-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a three-part Phase Ia study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of SYHA1805.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) or non-serious adverse events (AEs) Considered by the Investigator to be Related to Study Drug Administrationorally

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Day 28

Secondary Outcomes (6)

• 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

Part 1: Subjects will receive a single dose of oral SYHA1805 tablets. Part 2: Subjects will receive single ascending doses of SYHA1805 tablets. Part 3: Subjects will receive a single dose SYHA1805 tablets in a fasted state and a single dose of SYHA1805 tablets after a high-fat, high-calorie meal, with sequence determined by randomization.

Drug: Drug: SYHA1805 tablets

Placebo

PLACEBO COMPARATOR

Subjects will receive the matching placebo tablets.

Drug: Placebo

Interventions

Drug: SYHA1805 tablets DRUG

Oral tablets of SYHA1805 with several doses

SYHA1805

Placebo DRUG

Oral tablets of placebo with matching several 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);
• 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 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, and total serum bilirubin are greater than 2 times the upper limits of normal (ULN) or other liver function test abnormalities, 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;
• 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

Central Study Contacts

Chanjuan Wang

CONTACT

15226599687; wangchanjuan@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 27, 2020
• Study Start: December 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 27, 2020

Record last verified: 2020-06