HealthyPhase 1NCT04555850

A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers

A Phase 1 study testing Recombinant Human Thymosin β4 in people with Healthy, run by Beijing Northland Biotech. Co., Ltd. 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

Search all trials

Trial summary

The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Recombinant Human Thymosin β4
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteChina
Study dates: 30 Jul 2018to 26 Jul 2019
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Chinese healthy volunteers（male or female）.
Between 18 and 50 years of age.
Female subjects should weigh no less than 45 kg and male subjects should weigh no less than 50 kg.BMI between 19 and 28 kg/m2.
Good health condition, no history of unintentional, liver, kidney, digestive tract, immune system, nervous system, mental and metabolic abnormality, no family history of tumor.
Ability to communicate normally with medical staff, understand research requirements and comply with hospital regulations.
Voluntarily sign informed consent.

Who cannot join

Physical examination vital signs electrocardiogram and laboratory examination are not done or any result is judged to be clinically significant abnormal (judged by clinician).
ADA tests positive.
Smoking more than 5 cigarettes a day for the previous 3 months, or no guarantee to stop smoking during the trial.
Previous history of substance abuse or drug screening test positive.
Alcohol intake averaged more than 2 units per day (1 unit = 360mL beer,150mL wine or 45mL 40% alcohol liquor) or alcohol test positive in the first 3 months of inclusion.
Participated in another trial or used this drug within 3 months before inclusion.

Show all 13Show fewer

Any other drug was used within two weeks before the trial.
There is a significant clinical history of allergy, especially for drugs, protein preparations and biological products, especially for rh-tβ4 or any of its ingredients.
Blood donation or blood loss was equal to or greater than 400 mL within three months prior to the trial.
Female subjects who are pregnant or breast-feeding, or who are likely to become pregnant without using an acceptable method of contraception, or who are positive for a pregnancy test, and male subjects who are not using effective contraception or whose partner has a family planning plan within six months of the end of the trial.
Unable to tolerate venous blood collection.
There is no guarantee that smoking and taking grapefruit juice or any alcoholic and xanthine food and beverage (including chocolate, tea, coffee, cola, etc.) from 48 hours before administration to the last blood sample collection.
The investigator judges that the subject is unable to complete the study or otherwise considers that the subject's participation in the study may cause other injury.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Shijitan Hospital
Beijing

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled, Multiple Doses,Dose-escalation，Phase 1b Study of the Safety, Tolerability，Pharmacokinetics and the Potential Immunological Reaction of Recombinant Human Thymosin Beta4 in Chinese Healthy Volunteers

Read the detailed description

This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability pharmacokinetics and potential immune responses of multiple NL005 intravenous administration.

Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and 5.0 μg/kg for 10 consecutive days at a ratio of 4:1.

While observing the safety of the subjects in each dose group, about 5mL of venous blood was collected for the ADA study in healthy subjects 14 days and 28 days after the first administration of the drug.

Conditions: Healthy
Being tested: Recombinant Human Thymosin β4, Placebo
Keywords: Recombinant human thymosin β4

What participants receive

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

Recombinant Human Thymosin β4Drug
Also called rh-β4
Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.
PlaceboOther
3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .

Study groups in NCT04555850
Study group	Role	What they receive
Recombinant Human Thymosin β4 0.5ug/kg	Experimental	10 subjects in this group will receive NL005 for 0.5ug/kg respective.Continuous administration for 10 days. Receives: Drug: Recombinant Human Thymosin β4
Recombinant Human Thymosin β4 2.0ug/kg	Experimental	10 subjects in this group will receive NL005 for 2.0ug/kg respective.Continuous administration for 10 days. Receives: Drug: Recombinant Human Thymosin β4
Recombinant Human Thymosin β4 5.0ug/kg	Experimental	10 subjects in this group will receive NL005 for 5.0ug/kg respective.Continuous administration for 10 days. Receives: Drug: Recombinant Human Thymosin β4
Placebo	Other	Two subjects in each dose group (0.5/2/5ug/kg) were given placebo for 10 days.A total of six participants were given a placebo. Receives: Other: Placebo

What is being measured

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

Maximum Tolerated Dose (MTD) .
Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. In this study, DLT was defined as liver, kidney, heart and mental nervous system toxicity of level 2 or above or blood system toxicity of level 3 or above and other systemic adverse events occurred within 14 days after drug administration, and the adverse events were judged to be related to the experimental drug use.If more than 3 (including 3) DLT cases are present in any dose group, the test should be terminated. The previous dose of this dose is considered the maximum tolerated dose (MTD).
Measured: Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. All adverse events were determined according to NCI CTCAE4.03.CTCAE4.03 was classified into grades 1 to 5, in which grade 1 was mild adverse event and grade 5 was death due to adverse event.According to NCI CTCAE4.03.
Measured: Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28.
The Cmax of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The Tmax of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The MRT of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The AUClast of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The AUC0-inf of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The t1/2 of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The VZ of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The CL of multiple administration of rh-Tβ4.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measured: Day 1、2、3、4、5、6、7、8、9、10.
The potential immunological reaction (antibody formation) of multiple administration of rh-Tβ4.
Approximately 5mL venous blood was collected from subjects before, 14 days after, and 28 days after administration for ADA study of rh-Tβ4 in healthy subjects.After the 28th-day follow-up period, subjects who confirm that ADA results are positive should be reexamined every 30 days (±3 days) until the results turn negative or the titer level is stable for two consecutive times.
Measured: Day 1、14、28.

Timeline

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

30 Jul 201826 Jul 2019

First posted21 Sep 2020
Study start30 Jul 2018
Primary completion18 Feb 2019
Study completion26 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Dose Escalation for 3 Cohorts.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04555850
Sponsor's protocol ID: NL005-Ⅰ-2015-2
Status last verified: May 2020
First submitted: 8 May 2020
Last updated: 29 Sep 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: 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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-Controlled, Multiple Doses,Dose-escalation，Phase 1b Study of the Safety, Tolerability，Pharmacokinetics and the Potential Immunological Reaction of Recombinant Human Thymosin Beta4 in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT04555850
Acronym / sponsor ID: NL005-Ⅰ-2015-2
Conditions: Healthy
Keywords: Recombinant human thymosin β4
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Beijing Northland Biotech. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Jul 2018 (actual)
Primary completion: 18 Feb 2019 (actual)
Study completion: 26 Jul 2019 (actual)
First posted: 21 Sep 2020 (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.

Detailed description

Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and 5.0 μg/kg for 10 consecutive days at a ratio of 4:1.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Dose Escalation for 3 Cohorts.

Arm	Type	Receives
Recombinant Human Thymosin β4 0.5ug/kg	Experimental	Drug: Recombinant Human Thymosin β410 subjects in this group will receive NL005 for 0.5ug/kg respective.Continuous administration for 10 days.
Recombinant Human Thymosin β4 2.0ug/kg	Experimental	Drug: Recombinant Human Thymosin β410 subjects in this group will receive NL005 for 2.0ug/kg respective.Continuous administration for 10 days.
Recombinant Human Thymosin β4 5.0ug/kg	Experimental	Drug: Recombinant Human Thymosin β410 subjects in this group will receive NL005 for 5.0ug/kg respective.Continuous administration for 10 days.
Placebo	Other	Other: PlaceboTwo subjects in each dose group (0.5/2/5ug/kg) were given placebo for 10 days.A total of six participants were given a placebo.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Chinese healthy volunteers（male or female）.
Between 18 and 50 years of age.
Female subjects should weigh no less than 45 kg and male subjects should weigh no less than 50 kg.BMI between 19 and 28 kg/m2.
Good health condition, no history of unintentional, liver, kidney, digestive tract, immune system, nervous system, mental and metabolic abnormality, no family history of tumor.
Ability to communicate normally with medical staff, understand research requirements and comply with hospital regulations.

Key exclusion criteria (13 listed)

Physical examination vital signs electrocardiogram and laboratory examination are not done or any result is judged to be clinically significant abnormal (judged by clinician).
ADA tests positive.
Smoking more than 5 cigarettes a day for the previous 3 months, or no guarantee to stop smoking during the trial.
Previous history of substance abuse or drug screening test positive.
Alcohol intake averaged more than 2 units per day (1 unit = 360mL beer,150mL wine or 45mL 40% alcohol liquor) or alcohol test positive in the first 3 months of inclusion.

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
Recombinant Human Thymosin β4Also: rh-β4Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.	Drug	Recombinant Human Thymosin β4 0.5ug/kg, Recombinant Human Thymosin β4 2.0ug/kg, Recombinant Human Thymosin β4 5.0ug/kg
Placebo3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .	Other	Placebo

Primary outcome

Maximum Tolerated Dose (MTD) .
Time frame: Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28.
Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. In this study, DLT was defined as liver, kidney, heart and mental nervous system toxicity of level 2 or above or blood system toxicity of level 3 or above and other systemic adverse events occurred within 14 days after drug administration, and the adverse events were judged to be related to the experimental drug use.If more than 3 (including 3) DLT cases are present in any dose group, the test should be terminated. The previous dose of this dose is considered the maximum tolerated dose (MTD).
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Time frame: Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28.
Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. All adverse events were determined according to NCI CTCAE4.03.CTCAE4.03 was classified into grades 1 to 5, in which grade 1 was mild adverse event and grade 5 was death due to adverse event.According to NCI CTCAE4.03.
The Cmax of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The Tmax of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The MRT of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The AUClast of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The AUC0-inf of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The t1/2 of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The VZ of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The CL of multiple administration of rh-Tβ4.
Time frame: Day 1、2、3、4、5、6、7、8、9、10.
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
The potential immunological reaction (antibody formation) of multiple administration of rh-Tβ4.
Time frame: Day 1、14、28.
Approximately 5mL venous blood was collected from subjects before, 14 days after, and 28 days after administration for ADA study of rh-Tβ4 in healthy subjects.After the 28th-day follow-up period, subjects who confirm that ADA results are positive should be reexamined every 30 days (±3 days) until the results turn negative or the titer level is stable for two consecutive times.

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 29 Sep 2020.
Related InfoLink provided by the sponsor.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 Recombinant Human Thymosin β4 in people with Healthy, run by Beijing Northland Biotech. 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 6 inclusion and 13 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 29 Sep 2020. 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?

Maximum Tolerated Dose (MTD) . (time frame: Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28.). The study lists 11 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 NCT04555850.

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 29 Sep 2020.