Healthy ParticipantsPhase 1NCT06277167
A Phase I Study in Healthy Participants
A Phase 1 study testing Human interferon alfa 1b inhalation solution in people with Healthy Participants, run by Kexing Biopharm Co., Ltd. at 1 site in China.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Human interferon alfa 1b inhalation solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2023to 21 Apr 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 adult males or females aged 18-45 years;
- Male body weight ≥45 kg, male body weight ≥50 kg, and body mass index (BMI): 19.0-26.0 kg/m2 (both inclusive), BMI =body weight (kg)/height 2 (m2);
- The subjects voluntarily participate in the study and sign an informed consent form before the study.
Who cannot join
- Subjects who participated in any clinical studies of drugs or took study drugs within 3 months prior to the administration of study drug;
- Subjects who have undergone surgery within 3 months prior to screening or who plan to undergo surgery during the study or who have undergone surgery that would affect the absorption, distribution, metabolism, and excretion of drugs; subjects with a previous history of diseases of cardiovascular system, blood and lymphatic system, respiratory system, urinary system, endocrine, immune, mental and nervous system (such as epilepsy) that are clinically significant;
- Subjects with a history of respiratory system diseases, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, pulmonary interstitial disease, bronchial asthma, paradoxical bronchospasm, or throat ulcer and edema, or subjects with previous surgery of throat, trachea/bronchi and lung, or subjects with upper and lower respiratory tract infection and acute sinusitis caused by virus or bacteria within the 4 weeks prior to the use of study drug that are clinically significant or render them unsuitable to participate in the study in the opinion of the investigator;
- Subjects with ocular diseases or thyroid-related diseases that are clinically significant or render them unsuitable to participate in the study in the opinion of the investigator;
- Subjects with a history of drug allergy (antibiotics, interferon products, etc.), or a specific history of allergy (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergy to two or more drugs, food, pollen, etc.);
- Subjects who cannot tolerate aerosol inhalation;
Show all 22Show fewer
- Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or vitamins within14 days prior to screening;
- Subjects who have received vaccine within 4 weeks prior to the first dose, or subjects who plan to receive vaccine within 4 weeks after the last dose;
- Subjects who have had non-physiological blood loss of ≥300 mL within 3 months before the first dose (including trauma, blood collection, blood donation); or subjects who plan to donate blood during the study or within 30 days after the last dose;
- Subjects who have had a history of drug use or abuse within 6 months prior to screening;
- Subjects who have smoked within 3 months prior to screening, or who cannot stop using any tobacco products during the study;
- Subjects who have consumed more than 14 glasses of alcohol per week (1 glass =150 mL wine, or 360 mL beer, or 45 mL spirits) within 3 months prior to screening;
- Subjects who cannot tolerate venipuncture for blood collection or have potential blood collection difficulties, or subjects who feel dizzy and sick at the sight of blood or needle;
- Subjects who have special requirements for diet and cannot follow a standardized diet;
- Subjects who have a birth plan, or are unable to voluntarily take effective contraceptive measures, or have a sperm/egg donation plan during the study period and within 3 months after the last dose; female subjects who are pregnant or lactating;
- Subjects with clinically significant abnormalities on physical examinations, electrocardiograms, vital signs, chest X-rays, lung function, and laboratory tests (as judged by the clinician);
- Pulmonary function test: subjects with measured/predicted FEV1 ≤80% or FVC≤ 80% of expected value;
- Subjects who have positive urine nicotine test results;
- Subjects who have positive urine drug test results;
- Subjects who have positive alcohol breath results;
- Subjects who cannot use aerosol device correctly or who do not pass the aerosol dosing training;
- Subjects who cannot complete this study due to other reasons, or subjects who are unsuitable to participate in this clinical study due to other various reasons;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human Interferon Alfa 1b Inhalation Solution in Healthy Adult Subjects After Administration of Single Ascending Doses and Multiple Ascending Doses
A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses
Read the detailed description
Primary objective:To evaluate the tolerability and safety of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects.
Secondary objectives: To evaluate the pharmacokinetic (PK) profiles of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects and to evaluate the immunogenicity of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects
- Conditions
- Healthy Participants
- Being tested
- Human interferon alfa 1b inhalation solution, Human interferon alfa 1b inhalation solution placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human interferon alfa 1b inhalation solutionDrug
Participants will receive Human interferon alfa 1b inhalation solution orally for a single dose.
Human interferon alfa 1b inhalation solution placeboDrug
Participants will receive Human interferon alfa 1b inhalation solution placebo orally for a single dose.
Human interferon alfa 1b inhalation solutionDrug
Participants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study).
Human interferon alfa 1b inhalation solution placeboDrug
Participants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution placebo administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study).
| Study group | Role | What they receive |
|---|---|---|
| Human interferon alfa 1b inhalation solution (SAD) | Experimental | Human interferon alfa 1b inhalation solution：200,000 IU, 600,000 IU, 1,200,000 IU, and 1,80,000 IU dose groups Receives: Drug: Human interferon alfa 1b inhalation solution |
| Human interferon alfa 1b inhalation solution placebo (SAD) | Placebo comparator | Human interferon alfa 1b inhalation solution placebo ：200,000 IU, 600,000 IU, 1,200,000 IU, and 1,80,000 IU dose groups Receives: Drug: Human interferon alfa 1b inhalation solution placebo |
| Human interferon alfa 1b inhalation solution (MAD) | Experimental | Human interferon alfa 1b inhalation solution drug product：1,200,000 IU, and 1,80,000 IU dose groups Receives: Drug: Human interferon alfa 1b inhalation solution |
| Human interferon alfa 1b inhalation solution placebo (MAD) | Placebo comparator | Human interferon alfa 1b inhalation solution placebo ：1,200,000 IU, and 1,80,000 IU dose groups Receives: Drug: Human interferon alfa 1b inhalation solution placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
The adverse events and incidence of treatment-emergent adverse events(TEAEs)
Measured: Day 1 up to 29 or Day 1 up to 32
(ADRs)
The adverse events and incidence of adverse drug reactions (ADRs)
Measured: Day 1 up to 29 or Day 1 up to 32
(SAE)
The adverse events and incidence of serious adverse events (SAE)
Measured: Day 1 up to 29 or Day 1 up to 32
TEAEs that lead to subject discontinuation from the study
The adverse events and incidence of TEAEs that lead to subject discontinuation from the study
Measured: Day 1 up to 29 or Day 1 up to 32
Secondary outcomes (15)
Cmax After a Single Dose of GB05 Drug Product
The maximum concentration (Cmax) of GB05 Drug Product
Measured: Day 1 up to 3
Tmax After a Single Dose of GB05 Drug Product
The maximum concentration (Tmax) of GB05 Drug Product
Measured: Day 1 up to 3
AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product
The area under the concentration-time curve (AUC0-t and AUC0-inf) of GB05 Drug Product.
Measured: Day 1 up to 3
t1/2 After a Single Dose of GB05 Drug Product
The elimination half-life (t1/2) of GB05 Drug Product
Measured: Day 1 up to 3
Ke After a Single Dose of GB05 Drug Product
The elimination rate constant (Ke) of GB05 Drug Product
Measured: Day 1 up to 3
Vd After a Single Dose of GB05 Drug Product
The apparent distribution volume (Vd) of GB05 Drug Product.
Measured: Day 1 up to 3
MRT After a Single Dose of GB05 Drug Product
The average residence time (MRT) of GB05 Drug Product
Measured: Day 1 up to 3
CL After a Single Dose of GB05 Drug Product
The clearance rate (CL) of GB05 Drug Product
Measured: Day 1 up to 3
Cmax,ss After Multiple Doses of GB05 Drug Product
The maximum concentration at steady state (Cmax,ss) of GB05 Drug Product
Measured: Day 1 up to 10
Cmin,ss After Multiple Doses of GB05 Drug Product
The minimum concentration at steady state (Cmin,ss) of GB05 Drug Product
Measured: Day 1 up to 10
Css_av After Multiple Doses of GB05 Drug Product
The average steady-state plasma concentration (Css_av) of GB05 Drug Product
Measured: Day 1 up to 10
DF After Multiple Doses of GB05 Drug Product
The degree of fluctuation in the concentration during the dosing interval (DF) of GB05 Drug Product
Measured: Day 1 up to 10
(Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product
The fluctuation amplitude [(Cmax,ss-Cmin,ss)/Cmin,ss] of GB05 Drug Product
Measured: Day 1 up to 10
ADA
The Number and Percentage of Participants of anti-drug antibody (ADA)
Measured: Day 1 up to 29 or Day 1 up to 32
NAb
The Number and Percentage of Participants of neutralizing antibody (NAb).
Measured: Day 1 up to 29 or Day 1 up to 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start7 Jan 2023
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kexing Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guoxin Pharmaceutical Technology (Beijing) Co., Ltd., Changsha Third Hospital, Beijing SSYP Data Technology Development Co.,Ltd., United-Power Pharma Tech（Shanghai）Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277167
- Sponsor's protocol ID
- KXZY-GB05-101
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng H, Zhang W, Lin Y, Li H, Qin S. Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNalpha1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers. Infect Dis Ther. 2024 Sep;13(9):2053-2070. doi: 10.1007/s40121-024-01024-y. Epub 2024 Aug 4.
PubMed 39097549
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human Interferon Alfa 1b Inhalation Solution in Healthy Adult Subjects After Administration of Single Ascending Doses and Multiple Ascending Doses
- ClinicalTrials.gov ID
- NCT06277167
- Acronym / sponsor ID
- KXZY-GB05-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kexing Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guoxin Pharmaceutical Technology (Beijing) Co., Ltd., Changsha Third Hospital, Beijing SSYP Data Technology Development Co.,Ltd., United-Power Pharma Tech（Shanghai）Co., Ltd.
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 26 Feb 2024 (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.
A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses
Detailed description
Primary objective:To evaluate the tolerability and safety of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects.
Secondary objectives: To evaluate the pharmacokinetic (PK) profiles of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects and to evaluate the immunogenicity of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Human interferon alfa 1b inhalation solution (SAD) | Experimental | Drug: Human interferon alfa 1b inhalation solutionHuman interferon alfa 1b inhalation solution：200,000 IU, 600,000 IU, 1,200,000 IU, and 1,80,000 IU dose groups |
| Human interferon alfa 1b inhalation solution placebo (SAD) | Placebo comparator | Drug: Human interferon alfa 1b inhalation solution placeboHuman interferon alfa 1b inhalation solution placebo ：200,000 IU, 600,000 IU, 1,200,000 IU, and 1,80,000 IU dose groups |
| Human interferon alfa 1b inhalation solution (MAD) | Experimental | Drug: Human interferon alfa 1b inhalation solutionHuman interferon alfa 1b inhalation solution drug product：1,200,000 IU, and 1,80,000 IU dose groups |
| Human interferon alfa 1b inhalation solution placebo (MAD) | Placebo comparator | Drug: Human interferon alfa 1b inhalation solution placeboHuman interferon alfa 1b inhalation solution placebo ：1,200,000 IU, and 1,80,000 IU dose groups |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males or females aged 18-45 years;
- Male body weight ≥45 kg, male body weight ≥50 kg, and body mass index (BMI): 19.0-26.0 kg/m2 (both inclusive), BMI =body weight (kg)/height 2 (m2);
- The subjects voluntarily participate in the study and sign an informed consent form before the study.
Key exclusion criteria (22 listed)
- Subjects who participated in any clinical studies of drugs or took study drugs within 3 months prior to the administration of study drug;
- Subjects who have undergone surgery within 3 months prior to screening or who plan to undergo surgery during the study or who have undergone surgery that would affect the absorption, distribution, metabolism, and excretion of drugs; subjects with a previous history of diseases of cardiovascular system, blood and lymphatic system, respiratory system, urinary system, endocrine, immune, mental and nervous system (such as epilepsy) that are clinically significant;
- Subjects with a history of respiratory system diseases, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, pulmonary interstitial disease, bronchial asthma, paradoxical bronchospasm, or throat ulcer and edema, or subjects with previous surgery of throat, trachea/bronchi and lung, or subjects with upper and lower respiratory tract infection and acute sinusitis caused by virus or bacteria within the 4 weeks prior to the use of study drug that are clinically significant or render them unsuitable to participate in the study in the opinion of the investigator;
- Subjects with ocular diseases or thyroid-related diseases that are clinically significant or render them unsuitable to participate in the study in the opinion of the investigator;
- Subjects with a history of drug allergy (antibiotics, interferon products, etc.), or a specific history of allergy (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergy to two or more drugs, food, pollen, etc.);
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 |
|---|---|---|
| Human interferon alfa 1b inhalation solutionParticipants will receive Human interferon alfa 1b inhalation solution orally for a single dose. | Drug | Human interferon alfa 1b inhalation solution (SAD) |
| Human interferon alfa 1b inhalation solution placeboParticipants will receive Human interferon alfa 1b inhalation solution placebo orally for a single dose. | Drug | Human interferon alfa 1b inhalation solution placebo (SAD) |
| Human interferon alfa 1b inhalation solutionParticipants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study). | Drug | Human interferon alfa 1b inhalation solution (MAD) |
| Human interferon alfa 1b inhalation solution placeboParticipants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution placebo administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study). | Drug | Human interferon alfa 1b inhalation solution placebo (MAD) |
Primary outcome
TEAEs
Time frame: Day 1 up to 29 or Day 1 up to 32
The adverse events and incidence of treatment-emergent adverse events(TEAEs)
(ADRs)
Time frame: Day 1 up to 29 or Day 1 up to 32
The adverse events and incidence of adverse drug reactions (ADRs)
(SAE)
Time frame: Day 1 up to 29 or Day 1 up to 32
The adverse events and incidence of serious adverse events (SAE)
TEAEs that lead to subject discontinuation from the study
Time frame: Day 1 up to 29 or Day 1 up to 32
The adverse events and incidence of TEAEs that lead to subject discontinuation from the study
15 secondary outcomes
Cmax After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
Tmax After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
t1/2 After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
Ke After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
Vd After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
MRT After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
CL After a Single Dose of GB05 Drug Product
Time frame: Day 1 up to 3
Cmax,ss After Multiple Doses of GB05 Drug Product
Time frame: Day 1 up to 10
Cmin,ss After Multiple Doses of GB05 Drug Product
Time frame: Day 1 up to 10
Css_av After Multiple Doses of GB05 Drug Product
Time frame: Day 1 up to 10
DF After Multiple Doses of GB05 Drug Product
Time frame: Day 1 up to 10
(Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product
Time frame: Day 1 up to 10
ADA
Time frame: Day 1 up to 29 or Day 1 up to 32
NAb
Time frame: Day 1 up to 29 or Day 1 up to 32
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 1 May 2024.
- Derived from this study: PubMed 39097549Peng H, Zhang W, Lin Y, Li H, Qin S. Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNalpha1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers. Infect Dis Ther. 2024 Sep;13(9):2053-2070. doi: 10.1007/s40121-024-01024-y. Epub 2024 Aug 4.
- 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 Human interferon alfa 1b inhalation solution in people with Healthy Participants, run by Kexing Biopharm Co., Ltd. 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 3 inclusion and 22 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 1 May 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?
TEAEs (time frame: Day 1 up to 29 or Day 1 up to 32). 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 NCT06277167, which also lists 1 linked publication.
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 1 May 2024.