HealthyPhase 1NCT04295356
To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17
A Phase 1 study testing CT-P17 in people with Healthy, run by Celltrion at 1 site in United States.
Trial summary
This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CT-P17
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 15 Nov 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects who meet all of the following criteria will be considered eligible to participate in the clinical study:
- Healthy male or female subjects, between the ages of 18 and 55 years, both inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead electrocardiogram [ECG], and clinical laboratory tests prior to the administration of the study drug).
- Subject with C-reactive protein ≤1.5 times the upper limit of normal (ULN).
- Subject has adequate liver function as determined by following results:
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 times ULN and
- Total bilirubin ≤1.5 times ULN.
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- Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. The subject has the ability and agrees to cooperate with the investigator and must sign and date the written informed consent prior to performing any of the screening procedures.
- BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth.
- Subject and their partner of childbearing potential must agree to use highly effective method of contraception as specified in Section 5.8.2 throughout the study and for 5 months after the administration of the study drug. A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Male and female subjects and their partners who have been surgically sterilized for less than 24 weeks prior to the date of informed consent must agree to use any medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential.
Who cannot join
- Subjects who meet any of the following criteria will not be considered eligible to participate in the clinical study:
- Subject has a medical history and/or condition including one or more of the following disease(s):
- History and/or current presence of clinically significant atopy (e.g., allergic asthma, eczematous dermatitis), known or suspected clinically relevant hypersensitivity or allergic reactions to any of the excipients of study drug, other murine and human proteins or immunoglobulin products.
- History of infection with hepatitis B (active or carrier of hepatitis B), hepatitis C, human immunodeficiency virus (HIV) or syphilis. However, a subject with history of hepatitis B virus is allowed if resolved. Subject will be enrolled based on hepatitis B infection eligibility criteria, specified in Section 6.2.3.
- History of invasive systemic fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis, etc.) or other opportunistic infections judged by the investigator, including local fungal infections or a history of herpes zoster.
- History of and/or current cardiac (including New York Heart Association class III/IV heart failure), gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological (including pancytopenia, aplastic anemia or blood dyscrasia, etc.), metabolic (including diabetes mellitus), or pulmonary disease classed as significant by the investigator.
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- History of any malignancy.
- History of systemic or local infection, a known risk for developing sepsis, and/or known active inflammatory process or evidence of an infection requiring in-patient hospitalization or intravenous antibiotics within 24 weeks prior to the administration of the study drug (Day 1).
- Subject is considered to have a significant abnormal cardiac function in investigator's discretion determined by the laboratory results.
- Subject underwent surgical intervention or an operation within 4 weeks prior to the administration of the study drug (Day 1) or plans to have a surgical procedure during the study period.
- Subject has active tuberculosis (TB), latent TB (defined as a positive result for interferon-γ release assay [IGRA] with no active lesion in examination of chest X-ray without any sign or symptom of TB), a history of TB, had close contact with a person with active TB or traveled to areas within a high incidence of TB within 8 weeks prior to the administration of the study drug (Day 1) or has plans to travel to the area in which TB is prevalent during the study period. If the result of IGRA is indeterminate at Screening, retest will be allowed only once during the Screening period. If the repeated IGRA result is again indeterminate or positive, the subject will be excluded from the study. If the repeated IGRA result is negative, the subject may be included in the study.
- Female subject is pregnant or lactating or planning to be pregnant or to breastfeed before, during, or within 5 months after the administration of the study drug (Day 1).
- Male subject is planning to father a child or donate sperm within 5 months after the administration of the study drug (Day 1).
- Subject has received tumor necrosis factor-α blockers, or subject who has had exposure of a biologic agent (including but not limited to monoclonal antibodies or fusion protein) within 6 months prior to the administration of the study drug (Day 1).
- Subject used prescription (excluding hormonal birth control), over-the-counter drugs, dietary supplements, or herbal remedies that could affect the outcome of the study within 2 weeks prior to the administration of the study drug (Day 1).
- Subject has undergone treatment with an investigational drug or participated in another clinical trial for healthy subject or bioequivalence test within 90 days or 5 half-lives (whichever is longer) prior to the administration of the study drug (Day 1) or plan to do so during the study.
- Subject received a live or live-attenuated vaccine within 4 weeks prior to the administration of the study drug (Day 1) or plan to do so until the 6 months after Day 1.
- Subject has donated or lost 450 mL or more of whole blood within 8 weeks, or donated blood components within 4 weeks prior to the administration of the study drug (Day 1).
- Subject shows reasonable evidence of drug abuse (positive result for drug urine test and/or the opinion of the investigator).
- Subject has a history or presence of regular consumption exceeding an average weekly intake of >21 units of alcohol in recent 12 weeks prior to the administration of the study drug (Day 1). One unit is equivalent to a half-pint (285 mL) of beer/lager, one measure (25 mL) of spirits, or one small glass (125 mL) of wine. Subject is unwilling to avoid use of alcohol or alcohol containing foods, medications, or beverages within 24 hours prior to admission (Day -1), and each study visit until completion of the study.
- Subject has smoked 10 or more cigarettes per day in the recent 12 weeks prior to the administration of the study drug (Day 1) and/or is unable to refrain from smoking up to 24 hours after the administration of the study drug.
- In the opinion of the investigator, the subject is not eligible for the study participation for any reason (including clinical laboratory results) or shows evidence of a condition (e.g., psychological or emotional problem, any disorder or resultant therapy) that is likely to invalidate an informed consent or limit the ability of the subject to comply with the protocol requirements. Subject is unable to understand the protocol requirements, instructions, study-related restrictions, or the nature, scope, and possible consequences of the clinical study or is unable to give written informed consent or to comply fully with the protocol.
- Subject is vulnerable (e.g., employees of the study center or any other individuals involved with the conduct of the study, or immediate family members of such individuals, persons kept in prison, or other institutionalized persons by law enforcement).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17 in Healthy Subjects
This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm, all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks during which PK, safety, and immunogenicity measurements were made. The randomization to treatment assignment was stratified by body weight (≥80 kg vs. <80 kg) as measured on baseline (Day -1), gender (male vs. female) and study center.
- Conditions
- Healthy
- Being tested
- CT-P17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P17Biological
subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
CT-P17Biological
subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Auto injector | Active comparator | a single dose (40 mg) of CT-P17 via AI Receives: Biological: CT-P17 |
| Pre-filled syringe | Active comparator | a single dose (40 mg) of CT-P17 via PFS Receives: Biological: CT-P17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf)
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last))
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Secondary outcomes (7)
Time to Maximum Serum Concentration (Tmax)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Terminal Elimination Half-life (t1/2)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Terminal Elimination Rate Constant (λz)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Apparent Total Body Clearance (CL/F)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap)
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Summary of Immunogenicity Assay
To evaluate immunogenicity of CT-P17 SC administration via AI versus PFS in healthy subjects
Measured: Day 1 predose, Days 15, 29, 57, 71 postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start21 Jun 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Hyun Kim, Dr, Study director, Celltrion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295356
- Sponsor's protocol ID
- CT-P17 1.3
- Status last verified
- Jan 2021
- First submitted
- 1 Mar 2020
- Last updated
- 19 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Davidson A, Brimhall D, Kay J, Keystone E, Lee SJ, Kim SH, Bae YJ, Choi EJ, Furst DE. Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects. Br J Clin Pharmacol. 2021 Nov;87(11):4323-4333. doi: 10.1111/bcp.14850. Epub 2021 May 9.
PubMed 33822406
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04295356
- Acronym / sponsor ID
- CT-P17 1.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 7 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study, which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm, all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks during which PK, safety, and immunogenicity measurements were made. The randomization to treatment assignment was stratified by body weight (≥80 kg vs. <80 kg) as measured on baseline (Day -1), gender (male vs. female) and study center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto injector | Active comparator | Biological: CT-P17a single dose (40 mg) of CT-P17 via AI |
| Pre-filled syringe | Active comparator | Biological: CT-P17a single dose (40 mg) of CT-P17 via PFS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects who meet all of the following criteria will be considered eligible to participate in the clinical study:
- Healthy male or female subjects, between the ages of 18 and 55 years, both inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead electrocardiogram [ECG], and clinical laboratory tests prior to the administration of the study drug).
- Subject with C-reactive protein ≤1.5 times the upper limit of normal (ULN).
- Subject has adequate liver function as determined by following results:
- Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. The subject has the ability and agrees to cooperate with the investigator and must sign and date the written informed consent prior to performing any of the screening procedures.
Key exclusion criteria (23 listed)
- Subjects who meet any of the following criteria will not be considered eligible to participate in the clinical study:
- Subject has a medical history and/or condition including one or more of the following disease(s):
- Subject is considered to have a significant abnormal cardiac function in investigator's discretion determined by the laboratory results.
- Subject underwent surgical intervention or an operation within 4 weeks prior to the administration of the study drug (Day 1) or plans to have a surgical procedure during the study period.
- Subject has active tuberculosis (TB), latent TB (defined as a positive result for interferon-γ release assay [IGRA] with no active lesion in examination of chest X-ray without any sign or symptom of TB), a history of TB, had close contact with a person with active TB or traveled to areas within a high incidence of TB within 8 weeks prior to the administration of the study drug (Day 1) or has plans to travel to the area in which TB is prevalent during the study period. If the result of IGRA is indeterminate at Screening, retest will be allowed only once during the Screening period. If the repeated IGRA result is again indeterminate or positive, the subject will be excluded from the study. If the repeated IGRA result is negative, the subject may be included in the study.
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 |
|---|---|---|
| CT-P17subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks | Biological | Auto injector |
| CT-P17subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks | Biological | Pre-filled syringe |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last))
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
7 secondary outcomes
Time to Maximum Serum Concentration (Tmax)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Terminal Elimination Half-life (t1/2)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Terminal Elimination Rate Constant (λz)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Apparent Total Body Clearance (CL/F)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap)
Time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Summary of Immunogenicity Assay
Time frame: Day 1 predose, Days 15, 29, 57, 71 postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33822406Davidson A, Brimhall D, Kay J, Keystone E, Lee SJ, Kim SH, Bae YJ, Choi EJ, Furst DE. Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects. Br J Clin Pharmacol. 2021 Nov;87(11):4323-4333. doi: 10.1111/bcp.14850. Epub 2021 May 9.
- Individual participant dataSharing planned: Undecided
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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.
Sung Hyun Kim, Dr study director
Celltrion
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 CT-P17 in people with Healthy, run by Celltrion at 1 site in United States.
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 9 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 19 Jan 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Plasma Concentration (Cmax) (time frame: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose). The study lists 3 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 NCT04295356, 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 19 Jan 2021.