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CompletedNCT05955027QTc-ZX-7101AUpdated Nov 4, 2024

A Study to Evaluate the Effect of a Single Oral Dose of ZX-7101A on the QTc Interval in Healthy Subjects

A Phase 1 interventional study of ZX-7101A and Placebo in Influenza, Human, sponsored by Nanjing Zenshine Pharmaceuticals. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by Nanjing Zenshine Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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)

02

Conditions studied

  • Influenza, Human

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 24 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Nanjing Zenshine Pharmaceuticals is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    80mg group

    D1, two 40mg tablets and two placebo tablets

    Drug: ZX-7101A · Drug: Placebo

  • Experimental
    160mg group

    D1, four 40mg tablets

    Drug: ZX-7101A

  • Placebo comparator
    Placebo group

    D1, 4 placebo tablets

    Drug: Placebo

Interventions

  • DrugZX-7101A

    a drug to treat influenza, oral

  • DrugPlacebo

    placebo control, oral

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

Secondary outcomes

  1. T wave

    T-wave morphology,or absence

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

  2. PK parameters

    Cmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

  3. TEAE

    Rate of Treatment-Emergent Adverse Events(TEAE)

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

  4. U wave

    U-wave presence and absence

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

  5. PK parameters

    AUC0-t of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

  6. PK parameters

    AUCinf of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

  7. PK parameters

    Tmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)

    Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15

07

Study locations

1 site
  • Huashan Hospital affiliated to Fudan University
    Shanghai, Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05955027
Lead sponsor
Nanjing Zenshine Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Jul 8, 2023
Primary completion
Aug 5, 2023
Completion
Dec 15, 2023
Last update
Nov 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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