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HealthyPhase 1HHT120NCT05414734

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of HHT120 in Healthy Subjects

A Phase 1 study testing HHT120 in people with Healthy, run by Shanghai Synergy Pharmaceutical Sciences Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy Subjects and to assess the effects of food on the PK profile of single-dose of HHT120 in… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
HHT120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteChina
Study dates
1 Jul 2022to 1 Mar 2023
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

  • Subjects who understand and are willing to follow the clinical trial protocol to complete the study and sign the informed consent voluntarily
  • ≥50 kg, BMI 19.0-26.0 kg/m2 (including the critical value);
  • Those who have been proved healthy by medical history inquiry, physical examination and laboratory examination.

Who cannot join

  • Have a blood coagulation dysfunction or bleeding tendency, such as repeated bleeding gums, or nearly six months increased risk of bleeding events, or platelet count < 100 x 109 / L, or always have intracranial hemorrhage (after the accident, for example), gastrointestinal bleeding, purpura, or with active pathological bleeding, bleeding or have any family history, etc.
  • History of motor system, nervous/psychiatric system, endocrine system, blood circulation system, respiratory system, digestive system, urinary system, reproductive system abnormalities or existing diseases mentioned above, which the researcher judged to be clinically significant;
  • History of drug or food allergy, or are allergic to the active ingredients of the test drug and any excipient ingredients;
  • History of postural hypotension, fainting or coma;
  • High risk factors of TdP (hypokalemia, hypomagniemia, bradycardia, heart failure, hereditary long QT syndrome, etc.);
  • QTc interval greater than 450ms during screening;
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  • Undergone surgery within 3 months prior to or during screening, or have undergone surgery that affects drug absorption, distribution, metabolism or excretion, or plan to undergo surgery during the study period;
  • Blood donation or massive blood loss (≥400 mL) within 3 months before screening or during screening (except female menstrual period);
  • History of drug abuse or positive urine drug screening (morphine, THC, methylamphetamine, dimethylene dioxy-amphetamine, ketamine) within 5 years before screening;
  • Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup =250 mL) within 3 months prior to screening or during screening;
  • Drank regularly within 3 months prior to screening or during screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45mL 40% alcohol spirits or 150mL wine), who could not abstain from drinking during the test, or whose alcohol breath test results were > 0 mg/100mL;
  • Smoking ≥5 cigarettes per day in the previous 3 months in the screening period; Or unable to stop using any tobacco products in the treatment period;
  • Consumed a large amount of drinks or food (such as grapefruit, grapefruit juice, grapefruit jam, etc.) rich in grapefruit, pomelo, star fruit, mango and dragon fruit within the previous 14 days prior to screening; Or any beverage or food containing grapefruit (i.e. grapefruit), pomelo, star fruit, mango, dragon fruit within 48 hours before the first dose;
  • Special dietary requirements, unable to follow the uniform diet or dysphagia;
  • Lactose intolerant (who had diarrhea after drinking milk);
  • Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 14 days prior to screening;
  • Received vaccination within 28 days prior to or during screening;
  • Have participated in other clinical trials within 3 months prior to or during screening or who are not themselves participating in clinical trials;
  • Pregnant or lactating women, or abnormal pregnancy tests that are clinically significant as determined by the investigator; Male subjects (or their partners) or female subjects who have planned to have children during the entire study period and within 6 months after the study end and are unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, vasectomy, etc.) during the study period;
  • Female subjects with irregular menstruation or menstrual disorder (including menstrual cycle disorder, menstrual disorder and menorrhagia);
  • Those who cannot tolerate venipuncture or have difficulty in collecting blood;
  • Abnormal physical examination, blood routine examination, blood biochemistry, coagulation function, urine routine examination, 12-lead electrocardiogram examination, chest X-ray examination and clinical significance determined by the investigator;
  • Abnormal vital signs and abnormal retest;
  • Hepatitis B surface antigen, treponema pallidum antibody, human immunodeficiency virus antibody and hepatitis C antibody are abnormal and clinically significant as determined by researchers;
  • The investigator considers that the subjects are not suitable to participate in the study for other reasons or the subjects withdraw from the study for their own reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

Other trials in China

About this study

Official title: A Single and Multiple Assending Doses Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics and Food Effect After Administration of HHT120 Capsule in Healthy Subjects

This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy Subjects and to assess the effects of food on the PK profile of single-dose of HHT120 in healthy Subjects.

Read the detailed description

There are 3 parts of the study:

Part 1: Single asending dose trial; Part 2: Multiple asending dose trial; Part 3: Food effect trial ( 2-Period Crossover)

Conditions
Healthy
Being tested
HHT120, Placebo

What participants receive

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

  • HHT120Drug

    Also called PTI-011-Cl

    Capsule, oral administration

  • PlaceboDrug

    Capsule, oral administration

Study groups in NCT05414734
Study groupRoleWhat they receive
SAD HHT120ExperimentalSubjects will receive a single dose of HHT120 from 7 doses.
Receives: Drug: HHT120
SAD PlaceboPlacebo comparatorSubjects will receive a single dose of matched Placebo.
Receives: Drug: Placebo
MAD HHT120ExperimentalSubjects will receive a mutiple-dose of HHT120 twice daily for 7 days from 3 doses.
Receives: Drug: HHT120
MAD PlaceboPlacebo comparatorSubjects will receive a mutiple-dose of matched placebo twice daily for 7 days.
Receives: Drug: Placebo
FE K-CExperimentalSubjects will receive a single dose of HHT120 in the morning in fasted condition in Period 1; followed by a single dose of HHT120 administered in the morning in fed condition in Period 2. A washout period of 7 days will be maintained between 2 periods.
Receives: Drug: HHT120
FE C-KExperimentalSubjects will receive a single dose of HHT120 in the morning in fed condition in Period 1; followed by a single dose of HHT120 administered in the morning in fasted condition in Period 2. A washout period of 7 days will be maintained between 2 periods.
Receives: Drug: HHT120

What is being measured

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

  1. Vital signs

    Abnormal changes in vital signs from baseline

    Measured: Up to Day 14

  2. Physical examination

    Abnormal changes in physical examination from baseline

    Measured: Up to Day 14

  3. Laboratory examination

    Abnormal changes in laboratory examination from baseline

    Measured: Up to Day 14

  4. Electrocardiogram

    Abnormal changes in electrocardiogram from baseline

    Measured: Up to Day 14

  5. Chest radiography

    Abnormal changes in chest radiography from baseline

    Measured: Up to Day 14

  6. Adverse events

    Incidence of adverse events, serious adverse events, adverse events of special interest

    Measured: Up to Day 14

  7. Maximum tolerable dose (MTD)

    Maximum tolerable dose (MTD)

    Measured: Up to Day 14

Secondary outcomes (17)

  1. Part 1: Cmax

    Cmax of single dose administration

    Measured: Up to Day 4

  2. Part 1: Tmax

    Tmax of single dose administration

    Measured: Up to Day 4

  3. Part 1: t1/2

    t1/2 of single dose administration

    Measured: Up to Day 4

  4. Part 1: Vz/F

    Vz/F of single dose administration

    Measured: Up to Day 4

  5. Part 1: CLz/F

    CLz/F of single dose administration

    Measured: Up to Day 4

  6. Part 1: AUC

    AUC of single dose administration

    Measured: Up to Day 4

  7. Part 2: Cmax,ss

    Cmax,ss of multiple dose administration

    Measured: Up to Day 10

  8. Part 2: AUC,ss

    AUC,ss of multiple dose administration

    Measured: Up to Day 10

  9. Part 2: Tmax,ss

    tmax,ss of multiple dose administration

    Measured: Up to Day 10

  10. Part 2: Cmin,ss

    Cmin,ss of multiple dose administration

    Measured: Up to Day 10

  11. Part 2: Cav,ss

    Cav,ss of multiple dose administration

    Measured: Up to Day 10

  12. Part 2: t1/2

    t1/2 of multiple dose administration

    Measured: Up to Day 10

  13. Part 2: MRTss

    MRTss of multiple dose administration

    Measured: Up to Day 10

  14. Part 2: Accumulation index

    accumulation index of multiple dose administration

    Measured: Up to Day 10

  15. Part 1 & Part 2: aPTT, INR and TT

    Maximum percentage of aPTT, INR and TT to baseline (Emax)

    Measured: Up to Day 10

  16. Part 3: Cmax in fasted or fed condition

    Geometric mean ratios of Cmax (fed/fasted) and their 90% confidence intervals

    Measured: Up to Day 4

  17. Part 3: AUC in fasted or fed condition

    Geometric mean ratios of AUC (fed/fasted) and their 90% confidence intervals

    Measured: Up to Day 4

Timeline

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

  1. First posted10 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion15 Feb 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Why it stopped: Commercialization consideration. Without safety issues.

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414734
Sponsor's protocol ID
DTYX21037PⅠ
Acronym
HHT120
Status last verified
Jan 2023
First submitted
27 May 2022
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HHT120 in people with Healthy, run by Shanghai Synergy Pharmaceutical Sciences Co., Ltd. at 1 site in China.

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 3 inclusion and 25 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: withdrawn, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vital signs (time frame: Up to Day 14). The study lists 7 primary outcomes in all. 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 NCT05414734.

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 1 Feb 2023.

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