NCT04977570
Unknown
Phase 1
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.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 sites36 target enrollmentStarted: July 2021Last updated:
Overview
- Phase
- Phase 1
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 36
- Primary Endpoint
- Safety and tolerability of multiple-dose of SYHA1805
Overview
Brief Summary
This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose of SYHA1805.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Arms & Interventions
SYHA1805
Experimental
subjects will be randomized to receive multiple ascending doses of SYHA1805 tablets.
Intervention: SYHA1805 tablets (Drug)
Placebo
Placebo Comparator
subjects will be randomized to receive the matching placebo tablets.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of multiple-dose of SYHA1805
Time Frame: Baseline through Day 28
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.
Secondary Outcomes
- 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)
- Apparent clearance (CL/F)(Baseline through Day 28)
- Half time (t1/2)(Baseline through Day 28)
Investigators
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