Safety IssuesPhase 1NCT05217732
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
A Phase 1 study testing ZX-7101A in people with Safety Issues and Tolerance, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Tolerance, Pharmacokinetics
- 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
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 19 Dec 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
- Healthy adults age of 18-45 years old
- BMI in the range of 9~26 kg/m2; Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg
- In the judgement of the investigator, no clinically relevant abnormalities identified by a detailed medical history and full physical examination including BP and pulse rate measurement, or clinical laboratory tests
- Female subjects of nonchildbearing potential must be not pregnant or lactating. Subjects must consent and comply with the contraception requirement of the study.
- Able to understand the risks involved in the study, and provide written informed consent before the first study-specific procedure
- Able to understand and comply with the study procedures
Who cannot join
- History of hypersensitivity or allergy to drug or food
- History of clinically significant abnormalities such as metabolic, liver, kidney, blood, lung, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disorders; or in the judgement of the investigator, any medical abnormality that may be a concern to participate the study.
- Tympanic temperature >37.5℃, Pulse >100bmp or <50bmp, Systolic blood pressure ≥140mHg or ≤90mHg, or Diastolic blood pressure ≥90mHg or<50mHg
- Clinically relevant out-of-range baseline of total white cells or absolute neutrophil count
- Total bilirubin >1.5x ULN, AST >1.5 ULN or ALT >1.5ULN
- Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2
Show all 23Show fewer
- QTc interval > 450ms （ Fridericia's correction ， QTcF=QT/(RR^0.33) ）, QRS>120ms
- Acute respiratory tract infection within 2 weeks
- Any condition possibly affecting drug absorption, e.g. gastrectomy
- Received treatment of any prescription drug or alternative medicine within 4 weeks before first dosing or any nonprescription drug within 2 weeks or 5x half-life, whichever is longer
- Regular alcohol consumption >14units/week I the past 6 months or positive in alcohol breath test
- Use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day within 3 months
- Unwilling or unable to restrict the intake of caffeine or alcohol within 72 hours before dosing or during the in-patient observation period
- Use or intake of any known liver enzyme inducer or inhibitor within 14 days
- History of drug abuse or positive urine drug test
- Positive test for Hepatitis C antibody (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening
- Accumulative blood donation >400ml within 3 months or >200ml within 4 weeks or planning to donate during the study
- Pregnancy or lactating at screening
- Having difficulty of drawing blood from vein
- Treatment with an investigational drug or procedure within 3 months
- Received vaccination within 3 months or plan to be received vaccine during the study
- Received any surgical procedure within 3 months at screening
- Any other reason that, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University affiliated Huashan Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Randomized, Double-blind and Placebo-controled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of ZX-7101A and Its Food Effect in China Healthy Adult Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is to assess the food effect on ZX-7101A at a selected dose in a cross-over design.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Being tested
- ZX-7101A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-7101ADrug
tablet
PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Single dose of ZX-7101A treatment A | Experimental | Administrated as a single oral dose in healthy subjects Receives: Drug: ZX-7101A; Drug: Placebo |
| Single dose of ZX-7101A treatment B | Experimental | Administrated as a single oral dose in healthy subjects Receives: Drug: ZX-7101A; Drug: Placebo |
| Single dose of ZX-7101A treatment C | Experimental | Administrated as a single oral dose in healthy subjects Receives: Drug: ZX-7101A; Drug: Placebo |
| Single dose of ZX-7101A treatment D | Experimental | Administrated as a single oral dose in healthy subjects Receives: Drug: ZX-7101A; Drug: Placebo |
| Single dose of ZX-7101A treatment E | Experimental | Administrated as a single oral dose in healthy subjects Receives: Drug: ZX-7101A; Drug: Placebo |
| ZX-7101A food effect | Experimental | Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state. Receives: Drug: ZX-7101A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)
safety and tolerability
Measured: Day 1-day15
Secondary outcomes (4)
Peak plama concentration of ZX-7101A
To evaluate the maximum observed concentration (Cmax) after single oral dose of ZX-7101A
Measured: Days 1-15
Area under the plasma concentration of ZX-7101A
To evaluate the area under the curve (AUC) plasma-concentration after single oral dose of ZX-7101A
Measured: Days 1-15
Half-life of ZX-7101A
To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A
Measured: Days 1-15
Concentration of ZX-7101A in urine
To evaluate the concentration at a select treatment after single oral dose of ZX-7101A
Measured: Days 1-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Dec 2021
- Primary completion29 Aug 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Sequential
- Model description
- single ascending doses in part 1 and fasting/nonfasting crossover in part 2
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoli Qin, PhD, Study director, Zenshine Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217732
- Sponsor's protocol ID
- ZX-7101A-201
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind and Placebo-controled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of ZX-7101A and Its Food Effect in China Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05217732
- Acronym / sponsor ID
- ZX-7101A-201
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 1 Feb 2022 (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.
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is to assess the food effect on ZX-7101A at a selected dose in a cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- single ascending doses in part 1 and fasting/nonfasting crossover in part 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of ZX-7101A treatment A | Experimental | Drug: ZX-7101A, Drug: PlaceboAdministrated as a single oral dose in healthy subjects |
| Single dose of ZX-7101A treatment B | Experimental | Drug: ZX-7101A, Drug: PlaceboAdministrated as a single oral dose in healthy subjects |
| Single dose of ZX-7101A treatment C | Experimental | Drug: ZX-7101A, Drug: PlaceboAdministrated as a single oral dose in healthy subjects |
| Single dose of ZX-7101A treatment D | Experimental | Drug: ZX-7101A, Drug: PlaceboAdministrated as a single oral dose in healthy subjects |
| Single dose of ZX-7101A treatment E | Experimental | Drug: ZX-7101A, Drug: PlaceboAdministrated as a single oral dose in healthy subjects |
| ZX-7101A food effect | Experimental | Drug: ZX-7101AAdministered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults age of 18-45 years old
- BMI in the range of 9~26 kg/m2; Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg
- In the judgement of the investigator, no clinically relevant abnormalities identified by a detailed medical history and full physical examination including BP and pulse rate measurement, or clinical laboratory tests
- Female subjects of nonchildbearing potential must be not pregnant or lactating. Subjects must consent and comply with the contraception requirement of the study.
- Able to understand the risks involved in the study, and provide written informed consent before the first study-specific procedure
Key exclusion criteria (23 listed)
- History of hypersensitivity or allergy to drug or food
- History of clinically significant abnormalities such as metabolic, liver, kidney, blood, lung, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disorders; or in the judgement of the investigator, any medical abnormality that may be a concern to participate the study.
- Tympanic temperature >37.5℃, Pulse >100bmp or <50bmp, Systolic blood pressure ≥140mHg or ≤90mHg, or Diastolic blood pressure ≥90mHg or<50mHg
- Clinically relevant out-of-range baseline of total white cells or absolute neutrophil count
- Total bilirubin >1.5x ULN, AST >1.5 ULN or ALT >1.5ULN
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-7101Atablet | Drug | Single dose of ZX-7101A treatment A, Single dose of ZX-7101A treatment B, Single dose of ZX-7101A treatment C, Single dose of ZX-7101A treatment D, Single dose of ZX-7101A treatment E, ZX-7101A food effect |
| PlaceboTablet | Drug | Single dose of ZX-7101A treatment A, Single dose of ZX-7101A treatment B, Single dose of ZX-7101A treatment C, Single dose of ZX-7101A treatment D, Single dose of ZX-7101A treatment E |
Primary outcome
Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)
Time frame: Day 1-day15
safety and tolerability
4 secondary outcomes
Peak plama concentration of ZX-7101A
Time frame: Days 1-15
Area under the plasma concentration of ZX-7101A
Time frame: Days 1-15
Half-life of ZX-7101A
Time frame: Days 1-15
Concentration of ZX-7101A in urine
Time frame: Days 1-15
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 21 Jul 2023.
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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.
Xiaoli Qin, PhD study director
Zenshine Pharmaceuticals
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 Safety Issues and Tolerance, 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 23 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 21 Jul 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. 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?
Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs) (time frame: Day 1-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 21 Jul 2023.