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Healthy SubjectsPhase 1NCT04645901

A Study of SYHA1805 in Healthy Adult Subjects

A Phase 1 study testing Drug: SYHA1805 tablets in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Drug: SYHA1805 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2020to May 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.;
  • 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.

Trial locations and contacts

No sites are listed yet.

Chanjuan Wang contact

15226599687 ext. 0311-69085931

wangchanjuan@mail.ecspc.com

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase Ia Study in Healthy Adult Subjects to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of SYHA1805

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

Read the detailed description

This trial is divided into three parts: 1) The first part: Four Chinese healthy subjects will be included in the pre-test group to evaluate the safety, tolerability and pharmacokinetics after taking SYHA1805 tablets; 2) The second part: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics, several single ascending doses of SYHA1805 tablets or matching placebo tablets will be randomly administered to 24 Chinese healthy subjects under fasting condition; 3) The third part :To evaluate the food effect on the pharmacokinetic characteristics, a single dose SYHA1805 tablets will be administered to 12 Chinese healthy subjects under fed or fasted condition.

Being tested
Drug: SYHA1805 tablets, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: SYHA1805 tabletsDrug

    Oral tablets of SYHA1805 with several doses

  • PlaceboDrug

    Oral tablets of placebo with matching several doses

Study groups in NCT04645901
Study groupRoleWhat they receive
SYHA1805ExperimentalPart 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.
Receives: Drug: Drug: SYHA1805 tablets
PlaceboPlacebo comparatorSubjects will receive the matching placebo tablets.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline through Day 28

Secondary outcomes (6)

  1. 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

    Measured: Baseline through Day 28

  2. 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

    Measured: Baseline through Day 28

  3. 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

    Measured: Baseline through Day 28

  4. 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

    Measured: Baseline through Day 28

  5. 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

    Measured: Baseline through Day 28

  6. To evaluate the ECG result of single doses of SYHA1805 administered orally

    To analysis of the QT Interval after administration of of SYHA1805

    Measured: Baseline through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04645901
Sponsor's protocol ID
SYHA1805-CSP-001
Status last verified
Jun 2020
First submitted
17 Nov 2020
Last updated
27 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: SYHA1805 tablets in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chanjuan Wang (15226599687 ext. 0311-69085931, wangchanjuan@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline through Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04645901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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