Respiratory Viral InfectionPhase 1NCT06841926

Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males

A Phase 1 study testing ZX-7101A dry suspension and ZX-7101A tablet in people with Respiratory Viral Infection, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to evaluate the pharmacokinetics and relative bioavailability of metabolites in healthy Chinese adult males Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Respiratory Viral Infection
What is being tested?: ZX-7101A dry suspension and ZX-7101A tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 20 Feb 2025to 18 Apr 2025
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects aged 18 to 45 years (including the cut-off value, subject to the signing of the informed consent)
Body mass index (BMI) of 19 to 26 kg/m2 (including the cut-off value), with a body weight of at least 50 kg
Based on the medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), viral serology and chest X-ray results, the investigator judged that the subjects were in good general health (normal or abnormal examination results were not clinically significant).
Voluntary informed consent, no fertility and sperm donation plans within 90 days after the last dose of medication, and voluntary use of highly effective contraception (including a partner) (Nonpharmacologic contraception was required during the clinical trial)
Before signing the informed consent, the patients should have a full understanding of the trial content, process and possible adverse reactions, and voluntarily sign the informed consent.
Be able to complete the study in accordance with the protocol requirements

Who cannot join

Allergic (multiple drug and food allergies) or those who are likely to be allergic to the investigational drug or any component of the investigational drug as judged by the investigator;
Subjects with taste and smell dysfunction
Oral ulcer or mucosal injury
Subjects with a previous or present medical history of clinically abnormal metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurologic, or psychiatric disease who were deemed by the investigator to be ineligible for participation in the study
Subjects whose vital signs were abnormal and clinically significant before administration
Subjects with abnormal white blood cell or neutrophil count before administration that was judged by the investigators to be clinically significant;

Show all 24Show fewer

Before administration, the subjects had abnormal liver function: total bilirubin >1.5× upper limit of normal (ULN), AST >1.5× ULN, ALT >1.5× ULN;
Estimated glomerular filtration rate <90 mL/min/1.73 m2 (eGFR formula)
QTc interval > 450ms (Fridericia's correction, QTcF=QT/(RR^0.33)), QRS>120ms
Acute respiratory infection within 2 weeks before the study
Subjects who have difficulty swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, etc.); Or have a history of gastrointestinal surgery or resection that may alter the absorption and/or excretion of oral medications (subjects who have undergone appendectomy may be included)
Use of any prescription drug or Chinese herbal medicine within 4 weeks before trial initiation and use of over-the-counter or nutrual products (including multivalent cations, inhibitors, and metal supplements) within 2 weeks before trial initiation would require a longer interval of at least 5 half-ages of the drug
Subjects who had consumed more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) in the 6 months before screening or had received a positive breath test for alcohol
Smoking more than five cigarettes per day or habitual use of nicotine-containing products in the 3 months before screening.
Subjects who were unwilling to abstain from foods or drinks containing caffeine or alcohol that affect drug metabolism within 72 hours before drug administration and during the period of observation in phase I ward.
Use of any known liver enzyme inducer or liver enzyme inhibitor (grapefruit, orange juice, etc.) within 14 days before administration.
Subjects with a history of drug abuse (morphine, dimethyldioxyamphetamine, methamphetamines, tetrahydrocannabinol, ketamine, cocaine) or screening positive for drug abuse;
Subjects who were serologically positive for syphilis antibody (TP-trust), hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody;
Donating >400 mL within 3 months or >200 mL within 4 weeks prior to the screening period or planning to donate during the study period;
Those who have difficulty in venous blood collection;
Subjects who participated in other clinical trials or used any other clinical trial drugs or devices within 3 months before screening;
Vaccinated within 1 month prior to dose or planned to be vaccinated during the study period;
Subjects who had a surgical procedure within 6 months before screening or who were scheduled to undergo surgery during the trial;
Any other situation that the investigator considers may affect the subject's provision of informed consent or compliance with the trial protocol or completion of the trial according to the study process, or the subject's participation in the trial may affect the trial results or their own safety.Subjects who were serologically positive for syphilis antibody (TP-trust), hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody;

Trial locations and contacts

1 site in 1 country.

China1 site

West China Second University Hospital, Sichuan University and Children's Hospital Zhejiang University School of Medicine
Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Study to Evaluate the Pharmacokinetics of ZX-7101A for Suspension Versus Tablets in a Single Oral Administration Under Fasting Conditions in Healthy Chinese Adult Male Subjects

Study to evaluate the pharmacokinetics and relative bioavailability of metabolites in healthy Chinese adult males

Read the detailed description

To evaluate the pharmacokinetic profile and relative bioavailability of the active metabolite ZX-7101 (parent drug) after a single oral administration of 40 mg ZX-7101A for suspension and 40 mg ZX-7101A tablet in healthy Chinese adult male subjects

Conditions: Respiratory Viral Infection
Being tested: ZX-7101A dry suspension, ZX-7101A tablet

What participants receive

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

ZX-7101A dry suspensionDrug
Test formulation (T) : ZX-7101A dry suspension Specification: 10 mg/ bag Dosage：40 mg (4 bags)、 once
ZX-7101A tabletOther
Reference formulation (R): ZX-7101A tablet Specification: 40 mg/ tablet Dosage：40 mg (1 tablet)、 once

Study groups in NCT06841926
Study group	Role	What they receive
The test preparation was followed by the reference preparation	Other	Group 1: The test preparation was followed by the reference preparation: 20 subjects were given the test formulation (T) : ZX-7101A dry suspension 40 mg (4 bags) orally in the first cycle, and crossed over to the reference formulation ZX-7101A tablets 40 mg (1 tablet) in the second cycle, with a wash period of at least 21 days between two weeks. Receives: Drug: ZX-7101A dry suspension; Other: ZX-7101A tablet
The reference preparation was followed by the test preparation	Other	Group 2: The reference preparation was followed by the test preparation: 20 subjects were given reference formulation ZX-7101A tablets 40 mg (1 tablet) orally in the first cycle, and crossed over to the the test formulation (T) : ZX-7101A dry suspension 40 mg (4 bags) in the second cycle, with a wash period of at least 21 days between two weeks. Receives: Drug: ZX-7101A dry suspension; Other: ZX-7101A tablet

What is being measured

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

The pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug)
Pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Measured: From Day1 up to Day 36
The pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug)
Pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Measured: From Day1 up to Day 36
The pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug)
Pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Measured: From Day1 up to Day 36
Relative bioavailability of the active metabolite ZX-7101 (parent drug)
Relative bioavailability of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets.
Measured: From Day1 up to Day 36

Secondary outcomes (10)

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
To evaluate the safety and tolerability of a single oral administration of ZX-7101A dry suspension (40 mg/tablet) in healthy Chinese adult male subjects
Measured: From Day 1 up to Day 36
Cmax
To evaluate the pharmacokinetic: Cmax of ZX-7101A (prodrug) after a single oral administration of ZX-7101A dry suspension 40 mg and ZX-7101A tablets 40 mg in healthy Chinese adult male subjects
Measured: From Day 1 up to Day 36
AUC0-t
To evaluate the pharmacokinetic: AUC0-t of ZX-7101A (prodrug) after a single oral administration of ZX-7101A dry suspension 40 mg and ZX-7101A tablets 40 mg in healthy Chinese adult male subjects
Measured: From Day 1 up to Day 36
AUC0-inf
To evaluate the pharmacokinetic:AUC0-inf of ZX-7101A (prodrug) after a single oral administration of ZX-7101A dry suspension 40 mg and ZX-7101A tablets 40 mg in healthy Chinese adult male subjects
Measured: From Day 1 up to Day 36
Evaluation of palatability
The proportion of all subjects who received ZX-7101A dry suspension with a score ≥50 (including not good not bad, good, very good)
Measured: On Day 1
Tmax
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : Tmax
Measured: From Day 1 up to Day 36
Vz/F
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : Vz/F
Measured: From Day 1 up to Day 36
CL/F
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : CL/F
Measured: From Day 1 up to Day 36
t1/2
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : t1/2
Measured: From Day 1 up to Day 36
λz
PK parameters of prodrug ZX-7101A and its active metabolite ZX-7101 (parent drug) : λz
Measured: From Day 1 up to Day 36

Timeline

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

20 Feb 202518 Apr 2025

First posted24 Feb 2025
Study start20 Feb 2025
Primary completion18 Apr 2025
Study completion18 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Respiratory Viral InfectionStudies 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: Crossover
Model description: The study was a single-center, randomized, open-label, two-dose, two-cycle, two-sequence, double-crossover design. A total of 40 healthy male subjects were randomly divided into 2 sequences, 20 subjects in each sequence. Subjects received 40 mg of test preparation ZX-7101A dry suspension (4 bags) or 40 mg of reference preparation ZX-7101A tablets (1 tablet) per cycle. Subjects received either the test formulation (T) or the reference formulation (R) orally in the first cycle according to their random allocation of subjects, and crossed over to the reference formulation (R) or the test formulation (T) in the second cycle. The cleaning period was at least 21 days between the two weeks.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06841926
Sponsor's protocol ID: ZX-7101A-213
Status last verified: May 2025
First submitted: 13 Feb 2025
Last updated: 11 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics of ZX-7101A for Suspension Versus Tablets in a Single Oral Administration Under Fasting Conditions in Healthy Chinese Adult Male Subjects
ClinicalTrials.gov ID: NCT06841926
Acronym / sponsor ID: ZX-7101A-213
Conditions: Respiratory Viral Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Feb 2025 (actual)
Primary completion: 18 Apr 2025 (actual)
Study completion: 18 Apr 2025 (actual)
First posted: 24 Feb 2025 (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.

Study to evaluate the pharmacokinetics and relative bioavailability of metabolites in healthy Chinese adult males

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The study was a single-center, randomized, open-label, two-dose, two-cycle, two-sequence, double-crossover design. A total of 40 healthy male subjects were randomly divided into 2 sequences, 20 subjects in each sequence. Subjects received 40 mg of test preparation ZX-7101A dry suspension (4 bags) or 40 mg of reference preparation ZX-7101A tablets (1 tablet) per cycle. Subjects received either the test formulation (T) or the reference formulation (R) orally in the first cycle according to their random allocation of subjects, and crossed over to the reference formulation (R) or the test formulation (T) in the second cycle. The cleaning period was at least 21 days between the two weeks.

Arm	Type	Receives
The test preparation was followed by the reference preparation	Other	Drug: ZX-7101A dry suspension, Other: ZX-7101A tabletGroup 1: The test preparation was followed by the reference preparation: 20 subjects were given the test formulation (T) : ZX-7101A dry suspension 40 mg (4 bags) orally in the first cycle, and crossed over to the reference formulation ZX-7101A tablets 40 mg (1 tablet) in the second cycle, with a wash period of at least 21 days between two weeks.
The reference preparation was followed by the test preparation	Other	Drug: ZX-7101A dry suspension, Other: ZX-7101A tabletGroup 2: The reference preparation was followed by the test preparation: 20 subjects were given reference formulation ZX-7101A tablets 40 mg (1 tablet) orally in the first cycle, and crossed over to the the test formulation (T) : ZX-7101A dry suspension 40 mg (4 bags) in the second cycle, with a wash period of at least 21 days between two weeks.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy male subjects aged 18 to 45 years (including the cut-off value, subject to the signing of the informed consent)
Body mass index (BMI) of 19 to 26 kg/m2 (including the cut-off value), with a body weight of at least 50 kg
Based on the medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), viral serology and chest X-ray results, the investigator judged that the subjects were in good general health (normal or abnormal examination results were not clinically significant).
Voluntary informed consent, no fertility and sperm donation plans within 90 days after the last dose of medication, and voluntary use of highly effective contraception (including a partner) (Nonpharmacologic contraception was required during the clinical trial)
Before signing the informed consent, the patients should have a full understanding of the trial content, process and possible adverse reactions, and voluntarily sign the informed consent.

Key exclusion criteria (24 listed)

Allergic (multiple drug and food allergies) or those who are likely to be allergic to the investigational drug or any component of the investigational drug as judged by the investigator;
Subjects with taste and smell dysfunction
Oral ulcer or mucosal injury
Subjects with a previous or present medical history of clinically abnormal metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurologic, or psychiatric disease who were deemed by the investigator to be ineligible for participation in the study
Subjects whose vital signs were abnormal and clinically significant before administration

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-7101A dry suspensionTest formulation (T) : ZX-7101A dry suspension Specification: 10 mg/ bag Dosage：40 mg (4 bags)、 once	Drug	The reference preparation was followed by the test preparation, The test preparation was followed by the reference preparation
ZX-7101A tabletReference formulation (R): ZX-7101A tablet Specification: 40 mg/ tablet Dosage：40 mg (1 tablet)、 once	Other	The reference preparation was followed by the test preparation, The test preparation was followed by the reference preparation

Primary outcome

The pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug)
Time frame: From Day1 up to Day 36
Pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
The pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug)
Time frame: From Day1 up to Day 36
Pharmacokinetic parameters AUC0-t of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
The pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug)
Time frame: From Day1 up to Day 36
Pharmacokinetic parameters AUC0-inf of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets
Relative bioavailability of the active metabolite ZX-7101 (parent drug)
Time frame: From Day1 up to Day 36
Relative bioavailability of the active metabolite ZX-7101 (parent drug) in plasma after administration of ZX-7101A dry suspension /ZX-7101A tablets.

10 secondary outcomes

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From Day 1 up to Day 36
Cmax
Time frame: From Day 1 up to Day 36
AUC0-t
Time frame: From Day 1 up to Day 36
AUC0-inf
Time frame: From Day 1 up to Day 36
Evaluation of palatability
Time frame: On Day 1
Tmax
Time frame: From Day 1 up to Day 36
Vz/F
Time frame: From Day 1 up to Day 36
CL/F
Time frame: From Day 1 up to Day 36
t1/2
Time frame: From Day 1 up to Day 36
λz
Time frame: From Day 1 up to Day 36

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 11 May 2025.
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 dry suspension and ZX-7101A tablet in people with Respiratory Viral Infection, 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 6 inclusion and 24 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 11 May 2025. 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. 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?

The pharmacokinetic parameters Cmax of the active metabolite ZX-7101 (parent drug) (time frame: From Day1 up to Day 36). The study lists 4 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 NCT06841926.

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 11 May 2025.