COVID-19Phase 1NCT06864182
Relative Bioavailability Study of CX2101A for the Treatment of COVID-19
A Phase 1 study testing CX2101A tablet and CX2101A enteric-coated tablet in people with COVID-19 and Coronavirus Infection, run by Heronova Pharmaceuticals at 1 site in China.
Trial summary
The study comprises three parts: single ascending dose (SAD) studies of CX2101A tablets at 40 mg, 100 mg, and 160 mg; a relative bioavailability (BA) study comparing single-dose administration of 100 mg CX2101A tablets and enteric-coated tablets; and a multiple ascending dose (MAD) study of CX2101A tablets. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Coronavirus Infection
- What is being tested?
- CX2101A tablet and CX2101A enteric-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2024to 25 May 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged between 18 and 55 years old (including 18 and 55 years old), regardless of gender.
- For male volunteers, the body weight should be ≥ 50.0 kg, and for female volunteers, the body weight should be ≥ 45.0 kg. The body mass index (BMI) = body weight (kg) / height² (m²), and it should be within the range of 19.0 to 28.0 kg/m². Women of childbearing potential (WOCBP) or the female partners of male subjects should be willing to have no plans for childbearing from 2 weeks before the screening until 1 months after the last administration of the investigational medicinal product, and voluntarily adopt effective contraceptive measures (including one or more non-pharmacological contraceptive measures), and have no plans for sperm donation or egg donation.
- No history of major diseases, and the results of physical examination, vital signs, 12-lead electrocardiogram, chest X-ray examination and laboratory tests during the screening period are normal, or although slightly beyond the normal reference value range, they are judged by the investigator to have no clinical significance.
- The subject should be able to maintain good communication with the investigator, comply with various requirements of the clinical trial, and voluntarily sign the informed consent form.
Who cannot join
- Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded, including but not limited to those in the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases that affect drug absorption), hematological and lymphatic system, urinary system, endocrine system, and immune system.
- Acute diseases that occurred from the screening stage to before the first administration of the investigational medicinal product and are judged by the investigator to possibly affect the research results.
- Subjects who cannot tolerate intravenous puncture or those with a history of syncope judged by the investigator to be of clinical significance.
- Subjects with difficulty in swallowing.
- Subjects who are judged by the investigator to possibly or definitely have an allergic reaction to the investigational drug (including similar drugs), or any of its excipients; or subjects with an allergic constitution judged by the investigator to be of clinical significance (a history of severe allergies to multiple drugs and foods) or a history of allergic diseases.
- Subjects who have undergone surgery before screening and are judged by the investigator to possibly affect the absorption, distribution, metabolism, and excretion of the drug, or subjects with severe surgical sequelae, or subjects who plan to undergo surgery during the study period.
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- Subjects who donated blood or had massive blood loss (≥ 400 mL), donated ≥ 2 units of component blood, or received a blood transfusion within 3 months before screening, or those who plan to donate blood during the trial.
- Subjects who received any investigational drug in a clinical study or participated in any interventional clinical study within 3 months before screening.
- Subjects who smoked an average of more than 5 cigarettes per day within 3 months before screening, or those who cannot stop using any tobacco products during the trial.
- Subjects who consumed an average of more than 14 units of alcohol per week within 3 months before screening (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or those who cannot stop using any alcohol-containing products during the trial, or those with a positive alcohol breath test before the administration of the trial.
- Subjects who consumed an excessive amount of tea, coffee, and/or caffeine-containing beverages on average per day (more than 8 cups on average, 1 cup ≈ 250 mL) within 3 months before screening, or those who cannot stop consuming tea, coffee, and/or caffeine-containing beverages during the trial.
- Subjects who used any prescription drugs, over-the-counter drugs, traditional Chinese patent medicines, Chinese herbal medicines, vitamins, or health foods within 28 days before screening or within 5 drug half-lives (whichever is longer).
- Female subjects who are pregnant or breastfeeding, or those with a positive blood/urine pregnancy test (only for WOCBP) at any time during screening.
- Positive results or results exceeding the upper limit of the reference range for the four hemodialysis tests: hepatitis B surface antigen (HBsAg), quantitative hepatitis C (HCV) antibody, quantitative human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.
- Subjects with a positive urine drug screening (morphine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, ketamine) or those with a history of drug abuse or drug use within the past 5 years before the trial.
- Subjects who consumed or drank pitaya, mango, pomelo, carambola, or foods or beverages prepared from them, or foods or beverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that affect the absorption, distribution, metabolism, and excretion of the drug within 72 hours before screening.
- Subjects with special dietary requirements, lactose intolerance, those without a habit of eating breakfast, or those who cannot accept the unified diet.
- Subjects who, according to the investigator's judgment, are not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Relative Bioavailability of Single-Dose CX2101A Tablets and Enteric-Coated Tablets, and the Pharmacokinetics of Single and Multiple Doses of CX2101A Tablets in Healthy Adult Subjects
The study comprises three parts: single ascending dose (SAD) studies of CX2101A tablets at 40 mg, 100 mg, and 160 mg; a relative bioavailability (BA) study comparing single-dose administration of 100 mg CX2101A tablets and enteric-coated tablets; and a multiple ascending dose (MAD) study of CX2101A tablets. The BA study (100 mg) is integrated into the SAD study(Nested within the SAD protocol to optimize resource utilization).
Read the detailed description
- Randomized, Double-Blind, Placebo-Controlled Design All studies are conducted under standardized fasting conditions to eliminate food interference Blinding is maintained throughout the entire study period for both subjects and investigators
- Single Ascending Dose (SAD) Study Dose Groups: 40 mg, 100 mg, 160 mg (3 cohorts) Subject Allocation: 10 subjects/cohort (8 CX2101A + 2 placebo) Integration with BA Study: The 100 mg cohort will serve as the reference for bioavailability evaluation Subjects completing SAD phase will proceed to receive enteric-coated formulations
- Multiple Ascending Dose (MAD) Study Dose Groups: Same 40 mg, 100 mg, 160 mg cohorts Subject Allocation: 10 subjects/cohort (8 CX2101A + 2 placebo) Administration Schedule: Daily dosing for 5 consecutive days Relative Bioavailability (BA) Study
- Cohort Integration: Conducted within the 100 mg SAD group (N=10)
Treatment Sequence:
Initial single-dose administration of CX2101A tablets
≥7-day washout period (PK data-driven adjustment) Second single-dose administration of enteric-coated tablets
Subject Allocation:
CX2101A tablets group: 8 subjects (CX2101A + 8 placebo) Enteric-coated group: 8 subjects (CX2101A + 8 placebo)
- Conditions
- COVID-19, Coronavirus Infection
- Being tested
- CX2101A tablet, CX2101A placebo tablet, CX2101A enteric-coated tablet, CX2101A placebo enteric-coated tablet
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX2101A tabletDrug
CX2101A tablet
CX2101A placebo tabletDrug
CX2101A placebo tablet
CX2101A enteric-coated tabletDrug
CX2101A enteric-coated tablet
CX2101A placebo enteric-coated tabletDrug
CX2101A placebo enteric-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| CX2101A Placebo Tablet | Placebo comparator | Participants from SAD cohort received single dose of CX2101A placebo tablet orally. Participant from MAD cohort received CX2101A placebo tablet orally once daily for 5 days. Receives: Drug: CX2101A placebo enteric-coated tablet |
| CX2101A Tablet | Experimental | Participants from SAD cohort received single dose of CX2101A tablet orally. Participant from MAD cohort received CX2101A tablet orally once daily for 5 days. Dose levels are 40 mg, 100mg, 160mg. Receives: Drug: CX2101A tablet |
| CX2101A Placebo Enteric-Coated Tablet | Placebo comparator | Participants received single dose of CX2101A placebo enteric-coated tablet. Receives: Drug: CX2101A placebo tablet |
| CX2101A Enteric-Coated Tablet | Experimental | Participants received single dose of 100 mg CX2101A enteric-coated tablet. Receives: Drug: CX2101A enteric-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-t): The area under the plasma concentration-time curve from time zero to the last measurable concentration.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Area Under the Curve from Time Zero Extrapolated to Infinity (AUC0-∞): The area under the plasma concentration-time curve from time zero extrapolated to infinity.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time to Reach Peak Concentration (Tmax): The time at which the peak plasma concentration is reached.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Elimination Half-Life (T1/2): The time required for the plasma concentration to decrease by half.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Apparent Volume of Distribution (Vz/F): The volume into which the drug appears to be distributed, corrected for bioavailability.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Apparent Clearance (CL/F): The clearance of the drug from the plasma, corrected for bioavailability.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
PK profile of CX2101A and its metabolite CX210101 and CX210108
Percentage of AUC Extrapolated (AUC_%Extrap): The percentage of the total AUC that is extrapolated beyond the last measurable concentration.
Measured: From time zero up to 96 hours post-dose following last dose of CX2101A
Secondary outcomes (6)
Rate and severity of treatment-emergent adverse events (TEAEs)
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: From day 1 until 4 days after treatment
Vital signs
Number of participants with abnormal results of vital signs.
Measured: From day 1 until 4 days after treatment
Electrocardiogram (ECG)
Number of participants with abnormal results of electrocardiogram.
Measured: From day 1 until 4 days after treatment
Physical examinations
Number of participants with abnormal results of physical examinations
Measured: From day 1 until 4 days after treatment
Complete blood count test
Number of participants with abnormal results of complete blood count test.
Measured: From day 1 until 4 days after treatment
Clinical Chemistry
Number of participants with abnormal results of clinical chemistry.
Measured: From day 1 until 4 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start21 Mar 2024
- Primary completion25 May 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heronova Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864182
- Sponsor's protocol ID
- SHRC-CX2101-01-02
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Relative Bioavailability of Single-Dose CX2101A Tablets and Enteric-Coated Tablets, and the Pharmacokinetics of Single and Multiple Doses of CX2101A Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06864182
- Acronym / sponsor ID
- SHRC-CX2101-01-02
- Conditions
- COVID-19, Coronavirus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Heronova PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 7 Mar 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.
The study comprises three parts: single ascending dose (SAD) studies of CX2101A tablets at 40 mg, 100 mg, and 160 mg; a relative bioavailability (BA) study comparing single-dose administration of 100 mg CX2101A tablets and enteric-coated tablets; and a multiple ascending dose (MAD) study of CX2101A tablets. The BA study (100 mg) is integrated into the SAD study(Nested within the SAD protocol to optimize resource utilization).
Detailed description
- Randomized, Double-Blind, Placebo-Controlled Design All studies are conducted under standardized fasting conditions to eliminate food interference Blinding is maintained throughout the entire study period for both subjects and investigators
- Single Ascending Dose (SAD) Study Dose Groups: 40 mg, 100 mg, 160 mg (3 cohorts) Subject Allocation: 10 subjects/cohort (8 CX2101A + 2 placebo) Integration with BA Study: The 100 mg cohort will serve as the reference for bioavailability evaluation Subjects completing SAD phase will proceed to receive enteric-coated formulations
- Multiple Ascending Dose (MAD) Study Dose Groups: Same 40 mg, 100 mg, 160 mg cohorts Subject Allocation: 10 subjects/cohort (8 CX2101A + 2 placebo) Administration Schedule: Daily dosing for 5 consecutive days Relative Bioavailability (BA) Study
- Cohort Integration: Conducted within the 100 mg SAD group (N=10)
Treatment Sequence:
Initial single-dose administration of CX2101A tablets
≥7-day washout period (PK data-driven adjustment) Second single-dose administration of enteric-coated tablets
Subject Allocation:
CX2101A tablets group: 8 subjects (CX2101A + 8 placebo) Enteric-coated group: 8 subjects (CX2101A + 8 placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CX2101A Placebo Tablet | Placebo comparator | Drug: CX2101A placebo enteric-coated tabletParticipants from SAD cohort received single dose of CX2101A placebo tablet orally. Participant from MAD cohort received CX2101A placebo tablet orally once daily for 5 days. |
| CX2101A Tablet | Experimental | Drug: CX2101A tabletParticipants from SAD cohort received single dose of CX2101A tablet orally. Participant from MAD cohort received CX2101A tablet orally once daily for 5 days. Dose levels are 40 mg, 100mg, 160mg. |
| CX2101A Placebo Enteric-Coated Tablet | Placebo comparator | Drug: CX2101A placebo tabletParticipants received single dose of CX2101A placebo enteric-coated tablet. |
| CX2101A Enteric-Coated Tablet | Experimental | Drug: CX2101A enteric-coated tabletParticipants received single dose of 100 mg CX2101A enteric-coated tablet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers aged between 18 and 55 years old (including 18 and 55 years old), regardless of gender.
- For male volunteers, the body weight should be ≥ 50.0 kg, and for female volunteers, the body weight should be ≥ 45.0 kg. The body mass index (BMI) = body weight (kg) / height² (m²), and it should be within the range of 19.0 to 28.0 kg/m². Women of childbearing potential (WOCBP) or the female partners of male subjects should be willing to have no plans for childbearing from 2 weeks before the screening until 1 months after the last administration of the investigational medicinal product, and voluntarily adopt effective contraceptive measures (including one or more non-pharmacological contraceptive measures), and have no plans for sperm donation or egg donation.
- No history of major diseases, and the results of physical examination, vital signs, 12-lead electrocardiogram, chest X-ray examination and laboratory tests during the screening period are normal, or although slightly beyond the normal reference value range, they are judged by the investigator to have no clinical significance.
- The subject should be able to maintain good communication with the investigator, comply with various requirements of the clinical trial, and voluntarily sign the informed consent form.
Key exclusion criteria (18 listed)
- Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded, including but not limited to those in the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases that affect drug absorption), hematological and lymphatic system, urinary system, endocrine system, and immune system.
- Acute diseases that occurred from the screening stage to before the first administration of the investigational medicinal product and are judged by the investigator to possibly affect the research results.
- Subjects who cannot tolerate intravenous puncture or those with a history of syncope judged by the investigator to be of clinical significance.
- Subjects with difficulty in swallowing.
- Subjects who are judged by the investigator to possibly or definitely have an allergic reaction to the investigational drug (including similar drugs), or any of its excipients; or subjects with an allergic constitution judged by the investigator to be of clinical significance (a history of severe allergies to multiple drugs and foods) or a history of allergic diseases.
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 |
|---|---|---|
| CX2101A tabletCX2101A tablet | Drug | CX2101A Tablet |
| CX2101A placebo tabletCX2101A placebo tablet | Drug | CX2101A Placebo Enteric-Coated Tablet |
| CX2101A enteric-coated tabletCX2101A enteric-coated tablet | Drug | CX2101A Enteric-Coated Tablet |
| CX2101A placebo enteric-coated tabletCX2101A placebo enteric-coated tablet | Drug | CX2101A Placebo Tablet |
Primary outcome
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-t): The area under the plasma concentration-time curve from time zero to the last measurable concentration.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Area Under the Curve from Time Zero Extrapolated to Infinity (AUC0-∞): The area under the plasma concentration-time curve from time zero extrapolated to infinity.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Time to Reach Peak Concentration (Tmax): The time at which the peak plasma concentration is reached.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Elimination Half-Life (T1/2): The time required for the plasma concentration to decrease by half.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Apparent Volume of Distribution (Vz/F): The volume into which the drug appears to be distributed, corrected for bioavailability.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Apparent Clearance (CL/F): The clearance of the drug from the plasma, corrected for bioavailability.
PK profile of CX2101A and its metabolite CX210101 and CX210108
Time frame: From time zero up to 96 hours post-dose following last dose of CX2101A
Percentage of AUC Extrapolated (AUC_%Extrap): The percentage of the total AUC that is extrapolated beyond the last measurable concentration.
6 secondary outcomes
Rate and severity of treatment-emergent adverse events (TEAEs)
Time frame: From day 1 until 4 days after treatment
Vital signs
Time frame: From day 1 until 4 days after treatment
Electrocardiogram (ECG)
Time frame: From day 1 until 4 days after treatment
Physical examinations
Time frame: From day 1 until 4 days after treatment
Complete blood count test
Time frame: From day 1 until 4 days after treatment
Clinical Chemistry
Time frame: From day 1 until 4 days after treatment
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 14 Mar 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 CX2101A tablet and CX2101A enteric-coated tablet in people with COVID-19 and Coronavirus Infection, run by Heronova 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 4 inclusion and 18 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 14 Mar 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. 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?
PK profile of CX2101A and its metabolite CX210101 and CX210108 (time frame: From time zero up to 96 hours post-dose following last dose of CX2101A). The study lists 8 primary outcomes in all. 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 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.