A Study of SYHA1805 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Phase Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of SYHA1805 in Chinese Healthy Adult Subjects.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: SYHA1805 tablets; Drug: Placebo

Detailed Description

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics, multiple ascending doses of SYHA1805 tablets or matching placebo tablets will be randomly administered to 36 Chinese healthy subjects under fasting condition.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chanjuan Wang; Phone Number: 15226599687; Email: wangchanjuan@mail.ecspc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.;
• Donated blood ≥500 mL within 4 weeks before screening, or had severe blood loss in excess of 500 mL, or received blood transfusion within 8 weeks prior to screening;
• Have used any prescription drugs within the 4 weeks before screening, including antibiotics or Chinese herbal medicines; have used any Over-the-Counter (OTC) medications or food supplements (such as vitamins and calcium) within the 2 weeks before screening except for paracetamol (maximum 1000 mg per day), ibuprofen (maximum 2400 mg per day) and topical OTC drugs; have taken a drug within its 5 half-lives prior to the first dose of the study drug;
• Smoking, consumption of alcohol or food/beverages containing xanthine or caffeine, strenuous exercise, or taking foods that affect drug absorption, distribution, metabolism, and excretion (such as grapefruit-containing drinks) within 2 days prior to D-1 ;
• Pregnant or lactating women;
• Not suitable for this study as determined by the investigator due to other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SYHA1805; subjects will be randomized to receive multiple ascending doses of SYHA1805 tablets.	Drug: SYHA1805 tablets; Oral tablets of SYHA1805 with three pre-designed doses
PLACEBO_COMPARATOR: Placebo; subjects will be randomized to receive the matching placebo tablets.	Drug: Placebo; Oral tablets of placebo with matching doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum plasma concentration（Tmax）	Time to maximum plasma concentration（Tmax）after administration of of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals	Baseline through Day 28
Half time (t1/2)	The half time of SYHA1805 after administration are calculated under fasting conditions or under the food effect of high-fat, high-calorie meals	Baseline through Day 28
Apparent clearance (CL/F)	To assess the apparent clearance (CL/F) after administration of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals	Baseline through Day 28
Area under the plasma concentration versus time curve (AUC）	Area under the plasma concentration versus time curve (AUC) after administration of of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals	Baseline through Day 28
Peak Plasma Concentration (Cmax）	Peak Plasma Concentration (Cmax) after administration of of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals	Baseline through Day 28

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Study Director: Kun Lou, master, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (ACTUAL): July 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HA1806-CSP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No