Influenza, HumanPhase 1QTc-ZX-7101ANCT05955027
A Study to Evaluate the Effect of a Single Oral Dose of ZX-7101A on the QTc Interval in Healthy Subjects
A Phase 1 study testing ZX-7101A in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of a single oral dose of ZX-7101A on the QTc interval in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- ZX-7101A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2023to 15 Dec 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
- Healthy male or female subjects, 18-45 years of age, inclusive, at the time of signing the ICF.
- Weight: Male weight ≥50 kg, female weight ≥45 kg, BMI between 19.0 and 28.0 kg/m2 (including cut-off value), BMI= weight (kg)/height 2 (m2).
- The investigator judged the subjects to be in good overall health based on their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (routine blood work, urine work, blood biochemistry, coagulation function), viral serology, and chest X-ray results (normal or abnormal test results have no clinical significance).
- Female subjects of childbearing potential and male subjects with a partner of childbearing potential who voluntarily signed ICF should be no fertile, sperm/egg donation for 6 months (female) or 90 days (male) from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).
- Fully understand the trial content and possible adverse reactions, have the ability to communicate with researchers normally, while complying with study requirements, follow protocol procedures and restrictions, and be able to visit on time.
Who cannot join
- Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.
- Subjects with digestive tract disease or any condition that may affect drug absorption, such as a history of liver and gallbladder disease, gastrointestinal disease, gastrointestinal surgery (except appendectomy) or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
- Subjects with electrolyte metabolism disorders such as hyperkalemia, hypokalemia, hypermagnesia, hypomagnesia, hypercalcemia or hypocalcemia.
- Subjects who have a history of other risk factors for tachycardia, or a family history of a first-degree relative (i.e. biological parent, sibling, or child) of short QT syndrome, long QT syndrome, or sudden unexplained death in young age (≤40 years).
- Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.
- Subjects who have got acute respiratory infections within 2 weeks before screening; Or have a history of fungal infection.
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- For patients with abnormal vital signs (blood pressure, pulse rate, ear temperature) and clinically significant results, the abnormal values of each vital sign are: Body temperature (ear temperature) >37.5 ℃; Systolic blood pressure (recumbent) <90 mmHg or ≥140 mmHg;Diastolic blood pressure (lying) <50 mmHg or ≥90 mmHg; Pulse rate (lying position) <50 beats/min or >100 beats/min.
- QTcF interval > 450ms or < 300 ms (Fridericia's correction), or QRS>120ms.
- Subjects who have abnormal liver function: alanyl aminotransferase (ALT) or aspartate aminotransferase (AST) higher than the upper limit of normal or serum total bilirubin (TBIL) greater than 1.5 times the upper limit of normal, who judged clinical significance by investigators.
- Subjects estimate glomerular filtration rate <90 mL/min/1.73 m2.
- Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.
- Subjects with a history of drug abuse (morphine, dimethylene dioxyamphetamine, methamphetamine, THC, ketamine, cocaine) or who screened positive for drug abuse.
- Women who are pregnant or breastfeeding, or who test positive for blood pregnancy.
- Subjects who have used any P-gp or CYP inducer or inhibitor within 30 days before screening, or any prescription or Chinese herbal medicine within 4 weeks before the start of the trial, or over-the-counter or health care products (including polyvalent cations and metal supplements, etc.) within 2 weeks before the start of the trial; It should have a longer time interval if the elimination half-life is longer-at least 5 elimination half-lives for the drug.
- Subjects who consumed more than 14 units of alcohol per week in the 6 months prior before screening (1 unit of alcohol =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or had a positive alcohol breath test or could not abstain during the trial.
- Subjects who smoked more than 5 cigarettes per day in the 3 months prior before screening or habitually used nicotine-containing products or could not give up during the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
About this study
The purpose of this study is to evaluate the effect of a single oral dose of ZX-7101A on the QTc interval in healthy subjects.
Read the detailed description
Day 1, Oral fasting administration of ZX-7101A tablets 80mg, 160mg and placebo, 6 visit periods were set from days 2 to 15(Day2, Day3, Day5, Day7, Day10, Day15)
- Conditions
- Influenza, Human
- Being tested
- ZX-7101A, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-7101ADrug
a drug to treat influenza, oral
PlaceboDrug
placebo control, oral
| Study group | Role | What they receive |
|---|---|---|
| 80mg group | Experimental | D1, two 40mg tablets and two placebo tablets Receives: Drug: ZX-7101A; Drug: Placebo |
| 160mg group | Experimental | D1, four 40mg tablets Receives: Drug: ZX-7101A |
| Placebo group | Placebo comparator | D1, 4 placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔΔQTc -Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc)
Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc) at designed time after single oral administration of ZX-7101A tablets 80mg and 160mg in healthy Chinese adults. ΔΔQTc：The change of QTc interval from baseline value (ΔQTc) at each time point after administration was calculated, and then the difference of ΔQTc between the experimental group and the placebo group at each time point was calculated(ΔΔQTc).
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
Secondary outcomes (7)
T wave
T-wave morphology,or absence
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Cmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
TEAE
Rate of Treatment-Emergent Adverse Events(TEAE)
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
U wave
U-wave presence and absence
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
AUC0-t of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
AUCinf of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Tmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Measured: Day1, Day2, Day3, Day5, Day7, Day10, Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start8 Jul 2023
- Primary completion5 Aug 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955027
- Sponsor's protocol ID
- ZX-7101A-206
- Acronym
- QTc-ZX-7101A
- Status last verified
- Oct 2024
- First submitted
- 14 Jun 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of a Single Oral Dose of ZX-7101A on the QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05955027
- Acronym / sponsor ID
- QTc-ZX-7101A / ZX-7101A-206
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of a single oral dose of ZX-7101A on the QTc interval in healthy subjects.
Detailed description
Day 1, Oral fasting administration of ZX-7101A tablets 80mg, 160mg and placebo, 6 visit periods were set from days 2 to 15(Day2, Day3, Day5, Day7, Day10, Day15)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 80mg group | Experimental | Drug: ZX-7101A, Drug: PlaceboD1, two 40mg tablets and two placebo tablets |
| 160mg group | Experimental | Drug: ZX-7101AD1, four 40mg tablets |
| Placebo group | Placebo comparator | Drug: PlaceboD1, 4 placebo tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects, 18-45 years of age, inclusive, at the time of signing the ICF.
- Weight: Male weight ≥50 kg, female weight ≥45 kg, BMI between 19.0 and 28.0 kg/m2 (including cut-off value), BMI= weight (kg)/height 2 (m2).
- The investigator judged the subjects to be in good overall health based on their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (routine blood work, urine work, blood biochemistry, coagulation function), viral serology, and chest X-ray results (normal or abnormal test results have no clinical significance).
- Female subjects of childbearing potential and male subjects with a partner of childbearing potential who voluntarily signed ICF should be no fertile, sperm/egg donation for 6 months (female) or 90 days (male) from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).
- Fully understand the trial content and possible adverse reactions, have the ability to communicate with researchers normally, while complying with study requirements, follow protocol procedures and restrictions, and be able to visit on time.
Key exclusion criteria (16 listed)
- Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.
- Subjects with digestive tract disease or any condition that may affect drug absorption, such as a history of liver and gallbladder disease, gastrointestinal disease, gastrointestinal surgery (except appendectomy) or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
- Subjects with electrolyte metabolism disorders such as hyperkalemia, hypokalemia, hypermagnesia, hypomagnesia, hypercalcemia or hypocalcemia.
- Subjects who have a history of other risk factors for tachycardia, or a family history of a first-degree relative (i.e. biological parent, sibling, or child) of short QT syndrome, long QT syndrome, or sudden unexplained death in young age (≤40 years).
- Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZX-7101Aa drug to treat influenza, oral | Drug | 160mg group, 80mg group |
| Placeboplacebo control, oral | Drug | 80mg group, Placebo group |
Primary outcome
ΔΔQTc -Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc)
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc) at designed time after single oral administration of ZX-7101A tablets 80mg and 160mg in healthy Chinese adults. ΔΔQTc：The change of QTc interval from baseline value (ΔQTc) at each time point after administration was calculated, and then the difference of ΔQTc between the experimental group and the placebo group at each time point was calculated(ΔΔQTc).
7 secondary outcomes
T wave
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
TEAE
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
U wave
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZX-7101A in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 4 Nov 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ΔΔQTc -Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc) (time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2024.