COVID-19Phase 1NCT06205524
A Study to Evealuate Safety and Immunogenicity of TI-0010 SARS-CoV-2 Vaccine in Healthy Adults
A Phase 1 study testing TI-0010 in people with COVID-19 and COVID-19 Immunisation, run by National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, COVID-19 Immunisation
- What is being tested?
- TI-0010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 1 Feb 2025
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Participant shall be in good general health within the age range of 18 to 59 years old when signing ICF, and can comply with study procedures
- For participant of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy after signing ICF, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
- Participants have not received any SARS-CoV-2 vaccine before screening; Or if participants have previously received SARS-CoV-2 vaccination, who vaccinated at least 6 months from the last vaccination date.
- Participant has tested positive or had COVID-infection related symptoms at least 4 months prior to screening.
Who cannot join
- Arm 2/4 only: Individuals haven't completed full vaccination schedule with any approved or investigational COVID-19 vaccines.
- Individuals with clinically significant laboratory or ECG abnormalities at Screening.
- BMI >30 kg/m2 or <18 kg/m2
- Positive RT-PCR test for SARS-CoV-2 at the screening site
- Known exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 5 days
- Postive test for HBsAg or HCV
Show all 14Show fewer
- Participant is acutely ill 4 weeks prior to Day1, or feberile (body temperature no less than 37.3 Celcius 72 hours prior to or at Day 1
- Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screenin or is anticipating the need for immunosuppressive treatment at any time during participation in the study
- Participation in a study of investigational drug/device 30 days prior to Screening
- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
- History of sever adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention(s)
- Previous vaccination with any vaccine 28 days prior Screening
- Receipt of blood/plasma products or immunoglobulin 3 months prior Screening
- Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the individual inappropriate for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Of BengBu Medical College
Bengbu, Anhui, 233002
Xiaoli Li, Master, 15215520890, 158169847@qq.com
About this study
Official title: An Exploratory, Randomized, Double-Blind, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of TI-0010 Vaccine to Prevent COVID-19 Caused by SARS-CoV-2 in Healthy Adults Aged 18-59 Years
This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose (Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio.
Read the detailed description
This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose(Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio. Follow-up visits will occur Days 3,7,14 and 28 post each vaccination, as well as 3, 6, 9 and 12 months for the single dose recipients after vaccination and for those who receive two doses post the second vaccination. The primary objective is to evaluate the safety and tolerability of the TI-0010 vaccine in adults within 28 days post each vaccination. The secondary objective is to evaluate the humoral and cellular immune responses of the TI-0010 vaccine in adults after a single dose or two doses of vaccination, to evaluate the safety of the TI-0010 vaccine within 1 year after vaccination in the adult population and to evaluate the immune persistence of TI-0010 vaccine after a single dose and two doses of administration.
- Conditions
- COVID-19, COVID-19 Immunisation
- Being tested
- TI-0010, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI-0010Biological
Sterile liquid for injection
PlaceboBiological
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Participants will receive 2 intramuscular (IM) injections of either TI-0010 or Placebo at Dose Level 1 on Day 0 and Day 28 Receives: Biological: TI-0010; Biological: Placebo |
| cohort 2 | Experimental | Participants will receive 1 intramuscular (IM) injection of either TI-0010 or Placebo at Dose Level 1 on Day 0 Receives: Biological: TI-0010; Biological: Placebo |
| cohort 3 | Experimental | Participants will receive 2 intramuscular (IM) injections of either TI-0010 or Placebo at Dose Level 2 on Day 0 and Day 28 Receives: Biological: TI-0010; Biological: Placebo |
| cohort 4 | Experimental | Participants will receive 1 intramuscular (IM) injection of either TI-0010 or Placebo at Dose Level 2 on Day 0 Receives: Biological: TI-0010; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
solicited adverse events (AEs)
solicited adverse events (AEs)
Measured: Up to 14 days following each injection among all participants.
The incidence of abnormal changes in laboratory indicators (including blood routine, blood biochemistry, thyroid function, coagulation function, and urine routine. )
The incidence of abnormal changes in laboratory indicators (including blood routine, blood biochemistry, thyroid function, coagulation function, and urine routine. )
Measured: Up to 3 days following each injection among all participants.
Secondary outcomes (9)
Geometric mean titer(GMT) of SARS-CoV-2 neutralizing antibodies
Geometric mean titer(GMT) of SARS-CoV-2 neutralizing antibodies
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Geometric mean titer fold increase(GMI) of SARS-CoV-2 neutralizing antibodies compared to baseline
Geometric mean titer fold increase(GMI) of SARS-CoV-2 neutralizing antibodies compared to baseline
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Seroconversion rates(SCRs) of SARS-CoV-2 neutralizing antibodies
Seroconversion rates(SCRs) of SARS-CoV-2 neutralizing antibodies
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Geometric mean titer(GMT) of SARS-CoV-2 RBD-binding IgG
Geometric mean titer(GMT) of SARS-CoV-2 RBD-binding IgG
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Geometric mean titer fold increase(GMI) of SARS-CoV-2 RBD-binding IgG compared to baseline
Geometric mean titer fold increase(GMI) of SARS-CoV-2 RBD-binding IgG compared to baseline
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Seroconversion rates(SCRs) of SARS-CoV-2 RBD-binding IgG
Seroconversion rates(SCRs) of SARS-CoV-2 RBD-binding IgG
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
The ratio of IL-2, IL-4, IFN- γ and TNF- α in T lymphocyte subsets (CD4+，CD8+) and memory T cell subsets (CD4+，CD8+).
The ratio of IL-2, IL-4, IFN- γ and TNF- α in T lymphocyte subsets (CD4+，CD8+) and
Measured: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Incidence of unsolicited Adverse Events (AEs)
Incidence of unsolicited Adverse Events (AEs)
Measured: From the time of first dose vaccination to day 28 after Dose 2 for Cohort 1/3; Up to day 28 after vaccination for Cohort 2/4.
Incidence of Serious Adverse Events (SAEs), AE of Special Interest (AESIs), and Medically-attended Aes (MAAEs)
Incidence of Serious Adverse Events (SAEs), AE of Special Interest (AESIs), and Medically-attended Aes (MAAEs)
Measured: Day 0 to 12 months after Dose 2 for Cohort 1/3； Up to 12 months after vaccination for Cohort 2/4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start10 Jul 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Therorna
- Responsible party
- Principal investigator, Xiaoli Li, National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
- Investigators
- Xiaoli Li, Master, Principal investigator, Second Affiliated Hospital of Bengbu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205524
- Sponsor's protocol ID
- TI-0010-10102
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Double-Blind, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of TI-0010 Vaccine to Prevent COVID-19 Caused by SARS-CoV-2 in Healthy Adults Aged 18-59 Years
- ClinicalTrials.gov ID
- NCT06205524
- Acronym / sponsor ID
- TI-0010-10102
- Conditions
- COVID-19, COVID-19 Immunisation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical CollegeUniversity, hospital or other
- Collaborators
- Therorna
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 16 Jan 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.
This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose (Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio.
Detailed description
This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose(Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio. Follow-up visits will occur Days 3,7,14 and 28 post each vaccination, as well as 3, 6, 9 and 12 months for the single dose recipients after vaccination and for those who receive two doses post the second vaccination. The primary objective is to evaluate the safety and tolerability of the TI-0010 vaccine in adults within 28 days post each vaccination. The secondary objective is to evaluate the humoral and cellular immune responses of the TI-0010 vaccine in adults after a single dose or two doses of vaccination, to evaluate the safety of the TI-0010 vaccine within 1 year after vaccination in the adult population and to evaluate the immune persistence of TI-0010 vaccine after a single dose and two doses of administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Biological: TI-0010, Biological: PlaceboParticipants will receive 2 intramuscular (IM) injections of either TI-0010 or Placebo at Dose Level 1 on Day 0 and Day 28 |
| cohort 2 | Experimental | Biological: TI-0010, Biological: PlaceboParticipants will receive 1 intramuscular (IM) injection of either TI-0010 or Placebo at Dose Level 1 on Day 0 |
| cohort 3 | Experimental | Biological: TI-0010, Biological: PlaceboParticipants will receive 2 intramuscular (IM) injections of either TI-0010 or Placebo at Dose Level 2 on Day 0 and Day 28 |
| cohort 4 | Experimental | Biological: TI-0010, Biological: PlaceboParticipants will receive 1 intramuscular (IM) injection of either TI-0010 or Placebo at Dose Level 2 on Day 0 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Participant shall be in good general health within the age range of 18 to 59 years old when signing ICF, and can comply with study procedures
- For participant of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy after signing ICF, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.
- Participants have not received any SARS-CoV-2 vaccine before screening; Or if participants have previously received SARS-CoV-2 vaccination, who vaccinated at least 6 months from the last vaccination date.
- Participant has tested positive or had COVID-infection related symptoms at least 4 months prior to screening.
Key exclusion criteria (14 listed)
- Arm 2/4 only: Individuals haven't completed full vaccination schedule with any approved or investigational COVID-19 vaccines.
- Individuals with clinically significant laboratory or ECG abnormalities at Screening.
- BMI >30 kg/m2 or <18 kg/m2
- Positive RT-PCR test for SARS-CoV-2 at the screening site
- Known exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 5 days
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 |
|---|---|---|
| TI-0010Sterile liquid for injection | Biological | cohort 1, cohort 2, cohort 3, cohort 4 |
| Placebo0.9% sodium chloride (normal saline) injection | Biological | cohort 1, cohort 2, cohort 3, cohort 4 |
Primary outcome
solicited adverse events (AEs)
Time frame: Up to 14 days following each injection among all participants.
solicited adverse events (AEs)
The incidence of abnormal changes in laboratory indicators (including blood routine, blood biochemistry, thyroid function, coagulation function, and urine routine. )
Time frame: Up to 3 days following each injection among all participants.
The incidence of abnormal changes in laboratory indicators (including blood routine, blood biochemistry, thyroid function, coagulation function, and urine routine. )
9 secondary outcomes
Geometric mean titer(GMT) of SARS-CoV-2 neutralizing antibodies
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Geometric mean titer fold increase(GMI) of SARS-CoV-2 neutralizing antibodies compared to baseline
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Seroconversion rates(SCRs) of SARS-CoV-2 neutralizing antibodies
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Geometric mean titer(GMT) of SARS-CoV-2 RBD-binding IgG
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Geometric mean titer fold increase(GMI) of SARS-CoV-2 RBD-binding IgG compared to baseline
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Seroconversion rates(SCRs) of SARS-CoV-2 RBD-binding IgG
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
The ratio of IL-2, IL-4, IFN- γ and TNF- α in T lymphocyte subsets (CD4+，CD8+) and memory T cell subsets (CD4+，CD8+).
Time frame: Baseline, 7 days, 14 days, 28 days after Dose 1； 7 days, 14 days, 28 days after Dose 2（only for Cohort 1/3）； 3 months, 6 months, 9 months and 12 months
Incidence of unsolicited Adverse Events (AEs)
Time frame: From the time of first dose vaccination to day 28 after Dose 2 for Cohort 1/3; Up to day 28 after vaccination for Cohort 2/4.
Incidence of Serious Adverse Events (SAEs), AE of Special Interest (AESIs), and Medically-attended Aes (MAAEs)
Time frame: Day 0 to 12 months after Dose 2 for Cohort 1/3； Up to 12 months after vaccination for Cohort 2/4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoli Li, Master principal investigator
Second Affiliated Hospital of Bengbu Medical College
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 TI-0010 in people with COVID-19 and COVID-19 Immunisation, run by National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Jan 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli li, Master (15215520890, 158169847@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
solicited adverse events (AEs) (time frame: Up to 14 days following each injection among all participants.). The study lists 2 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 18 Jan 2024.