Neovascular Age-Related Macular Degeneration (nAMD)Phase 1NCT07406438
To Evaluate the Safety, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
A Phase 1 study testing GB10 in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD)
- What is being tested?
- GB10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesChina
- Study dates
- 12 Feb 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with choroidal neovascularization (CNV) secondary to AMD (nAMD); For the study eye, either no prior IVT anti-VEGF treatment (treatment-naïve patients) or the last injection of the prior IVT anti-VEGF treatment occurred > 3 months before the first dose, with investigator-assessed effectiveness of prior anti-VEGF therapy (previously treated patients).
- The study eye must have either subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity (as evidenced by subretinal fluid, subretinal hyper-reflective material, leakage, or hemorrhage);
- CNV lesion of all types (CNV lesion types in the study eye include predominantly classic, minimally classic, or occult [including polypoidal choroidal vasculopathy (PCV)]) with:
- Total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas by FFA;
- CNV component area of ≥ 50% of total lesion size by FFA;
- Active CNV confirmed by FFA (evidence of leakage);
Show all 9Show fewer
- CNV exudation confirmed by SD-OCT (presence of fluid).
- BCVA letter score in the study eye of 78-24 letters (inclusive) in ETDRS-like charts (20/32-20/320 Snellen equivalent) before the first dose;
- Willingness to participate in the study, to comply with the study protocol, and to provide signed informed consent.
Who cannot join
- CNV in the study eye due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;
- The study eye on FFA:
- Subretinal hemorrhage of > 50% of the total lesion area and/or that involves the fovea; or
- Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea;
- Any concurrent intraocular condition in the study eye (e.g., central serous chorioretinopathy [CSC], retinal pigment epithelial tear involving the macula, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction, retinal vein occlusion, etc.) that, in the opinion of the investigator, may either reduce the potential for visual improvement or require medical or surgical intervention;
- Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in the study eye (for study eye with prior refractive surgery or cataract surgery, preoperative refractive error demonstrating more than 8 diopters), or axial length >26.5 mm when reliable refractive assessment is unavailable;
Show all 25Show fewer
- Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as IOP≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye;
- Current or prior receipt of any treatment for the study eye, including but not limited to:
- IVT implantation or injection other than anti-VEGF drugs within 6 months before screening (e.g., steroids, transplasminogen activator, ocriplasmin, C₃F₈ gas, air filling);
- Periocular pharmacological interventions for retinal diseases within 6 months before screening (including subconjunctival, sub-tenon's, peribulbar, or retrobulbar injections);
- Laser/photodynamic therapies within 6 months before screening (including laser photocoagulation, verteporfin PDT, diode laser, or transpupillary thermotherapy);
- Cataract surgery within 3 months before screening, or corticosteroid treatment for complications of cataract surgery, or YAG (yttrium aluminum garnet) laser posterior capsulotomy;
- Prior other intraocular surgery (e.g., pars plana vitrectomy [PPV], glaucoma surgery [except YAG peripheral iridotomy >3 months prior], corneal transplant, or radiotherapy).
- Active intraocular inflammation (grade trace or above) in the study eye before the first dose;
- Current vitreous hemorrhage (grade trace or above) in the study eye before the first dose;
- Monocular vision or non-study eye BCVA < 24 letters before the first dose;
- History of any cardiovascular/cerebrovascular events within 6 months before the first dose, including but not limited to: stroke (cerebrovascular accident), myocardial infarction, unstable angina, ventricular arrhythmias, and heart failure ≥ NYHA Class II;
- History of major surgery within 6 months before the first dose or plan to undergo surgery during the study;
- History of other disease, metabolic dysfunction, abnormal physical examination finding, or clinical laboratory finding prompting reasonable suspicion of a condition that might affect interpretation of the results of the study or render the patient at high risk for treatment complications in the opinion of the investigator, including but not limited to:
- Hepatic/renal dysfunction (ALT/AST>2.5×ULN; Cr/BUN>2×ULN);
- Uncontrolled diabetes (HbA1c≥7.5%);
- Uncontrolled hypertension (resting SBP ≥160 mmHg and/or DBP ≥100 mmHg);
- Platelets<100×10⁹/L; or coagulation dysfunction (PT>3 sec above ULN; APTT >10 sec above ULN);
- Pregnant or nursing (lactating) women;
- Any other conditions deemed by the investigator to render the participant unsuitable for trial participation.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Hengxin Peng, 86-0755-23018589, penghengxin@kexing.com
Wenbing Wei, Dr
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Hengxin Peng, 86-0755-23018589, penghengxin@kexing.com
Xian Wang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Hengxin Peng, 86-0755-23018589, penghengxin@kexing.com
Lijun Shen, Dr
Sir Run Run Shaw Hospital (SRRSH), affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Hengxin Peng, 86-0755-23018589, penghengxin@kexing.com
Binghong Wang, Dr
Nanchang University Second Affiliated Hospital
Nanchang, Jiangxi, 330006
Hengxin Peng, 86-0755-23018589, penghengxin@kexing.com
Xiaolong Yin
Henan Provincial Eye Hospital
Zhengzhou, Henan, 450015
Hengxin Peng, 86-0755-23018589, penghengxin@kexing.com
Haoyi Guo
About this study
Official title: An Open-label, Multicenter, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD).
In SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD.
Read more
In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.
After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.
Read the detailed description
This is an open-label, multicenter, dose-escalating study in patients with nAMD. The study consists of two parts: single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD). It aims to evaluate the safety, tolerability, and PK/PD profile of single and multiple GB10 IVT injections in patients with nAMD, to investigate the efficacy of GB10, and to assess its immunogenicity.
In SAD, a single IVT of 6 doses (per-eye administration, the same below) will be administered to up to 36 treatment-naïve or previously treated patients with neovascular age-related macular degeneration (nAMD). Participants will be enrolled sequentially, starting with the lowest dose and progressing to the highest. The first participant of each cohort will serve as the sentinel participant. If no dose-limiting toxicities related to GB10 treatment are observed among the participants, escalation will proceed to the next higher dose level after approval from the safety review committee. Two doses, best balancing efficacy and safety, will be determined in SAD and then entered into MAD.
In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.
After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.
- Being tested
- GB10
- Keywords
- nAMD, GB10, PK/PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB10Drug
GB10 Intravitreal Injection with indicating dosage.
| Study group | Role | What they receive |
|---|---|---|
| SAD Dose 1 | Experimental | SAD Dose 1 IVT Receives: Drug: GB10 |
| SAD Dose 2 | Experimental | SAD Dose 2 IVT Receives: Drug: GB10 |
| SAD Dose 3 | Experimental | SAD Dose 3 IVT Receives: Drug: GB10 |
| SAD Dose 4 | Experimental | SAD Dose 4 IVT Receives: Drug: GB10 |
| SAD Dose 5 | Experimental | SAD Dose 5 IVT Receives: Drug: GB10 |
| SAD Dose 6 | Experimental | SAD Dose 6 IVT Receives: Drug: GB10 |
| MAD Dose 1 | Experimental | MAD Dose 1 IVT Receives: Drug: GB10 |
| MAD Dose 2 | Experimental | MAD Dose 2 IVT Receives: Drug: GB10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of ocular adverse events
Measured: From enrollment to the end of treatment at 12 weeks
The incidence and severity of non-ocular adverse events
Measured: From enrollment to the end of treatment at 12 weeks
(SAD) The change in best corrected visual acuity (BCVA) from baseline after 4 weeks of treatment
Measured: From enrollment to the end of treatment at 4 weeks
(MAD) The change in best corrected visual acuity (BCVA) from baseline after 12 weeks of treatment
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (12)
(SAD) Change in central retinal subfield thickness (CST) from baseline at 4 weeks of treatment
Measured: From enrollment to the end of treatment at 4 weeks
(MAD) Change in central retinal subfield thickness (CST) from baseline at 12 weeks of treatment
Measured: From enrollment to the end of treatment at 12 weeks
Time of receiving rescue therapy for nAMD activity
Measured: From enrollment to the end of treatment at 12 weeks
Positive rate of anti-drug antibody and neutralizing antibody of GB10
Measured: From enrollment to the end of treatment at 12 weeks
Area under the drug-time curve from 0 to time t of GB10
Measured: From enrollment to the end of treatment at 12 weeks
Area under the curve at the time of 0-infinity of GB10
Measured: From enrollment to the end of treatment at 12 weeks
Peak concentration of GB10
Measured: From enrollment to the end of treatment at 12 weeks
Peak time of GB10
Measured: From enrollment to the end of treatment at 12 weeks
Clearance rate of GB10
Measured: From enrollment to the end of treatment at 12 weeks
Half-life of GB10
Measured: From enrollment to the end of treatment at 12 weeks
VEGF concentration
Measured: From enrollment to the end of treatment at 12 weeks
Ang2 concentration
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start12 Feb 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- nAMD
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406438
- Sponsor's protocol ID
- KXZY-GB10-101
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT07406438
- Acronym / sponsor ID
- KXZY-GB10-101
- Keywords
- nAMD, GB10, PK/PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.Research network
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Feb 2026 (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 aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD).
In SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD.
In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.
After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.
Detailed description
This is an open-label, multicenter, dose-escalating study in patients with nAMD. The study consists of two parts: single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD). It aims to evaluate the safety, tolerability, and PK/PD profile of single and multiple GB10 IVT injections in patients with nAMD, to investigate the efficacy of GB10, and to assess its immunogenicity.
In SAD, a single IVT of 6 doses (per-eye administration, the same below) will be administered to up to 36 treatment-naïve or previously treated patients with neovascular age-related macular degeneration (nAMD). Participants will be enrolled sequentially, starting with the lowest dose and progressing to the highest. The first participant of each cohort will serve as the sentinel participant. If no dose-limiting toxicities related to GB10 treatment are observed among the participants, escalation will proceed to the next higher dose level after approval from the safety review committee. Two doses, best balancing efficacy and safety, will be determined in SAD and then entered into MAD.
In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.
After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- nAMD
| Arm | Type | Receives |
|---|---|---|
| SAD Dose 1 | Experimental | Drug: GB10SAD Dose 1 IVT |
| SAD Dose 2 | Experimental | Drug: GB10SAD Dose 2 IVT |
| SAD Dose 3 | Experimental | Drug: GB10SAD Dose 3 IVT |
| SAD Dose 4 | Experimental | Drug: GB10SAD Dose 4 IVT |
| SAD Dose 5 | Experimental | Drug: GB10SAD Dose 5 IVT |
| SAD Dose 6 | Experimental | Drug: GB10SAD Dose 6 IVT |
| MAD Dose 1 | Experimental | Drug: GB10MAD Dose 1 IVT |
| MAD Dose 2 | Experimental | Drug: GB10MAD Dose 2 IVT |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with choroidal neovascularization (CNV) secondary to AMD (nAMD); For the study eye, either no prior IVT anti-VEGF treatment (treatment-naïve patients) or the last injection of the prior IVT anti-VEGF treatment occurred > 3 months before the first dose, with investigator-assessed effectiveness of prior anti-VEGF therapy (previously treated patients).
- The study eye must have either subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity (as evidenced by subretinal fluid, subretinal hyper-reflective material, leakage, or hemorrhage);
- CNV lesion of all types (CNV lesion types in the study eye include predominantly classic, minimally classic, or occult [including polypoidal choroidal vasculopathy (PCV)]) with:
- BCVA letter score in the study eye of 78-24 letters (inclusive) in ETDRS-like charts (20/32-20/320 Snellen equivalent) before the first dose;
- Willingness to participate in the study, to comply with the study protocol, and to provide signed informed consent.
Key exclusion criteria (25 listed)
- CNV in the study eye due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;
- The study eye on FFA:
- Any concurrent intraocular condition in the study eye (e.g., central serous chorioretinopathy [CSC], retinal pigment epithelial tear involving the macula, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction, retinal vein occlusion, etc.) that, in the opinion of the investigator, may either reduce the potential for visual improvement or require medical or surgical intervention;
- Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in the study eye (for study eye with prior refractive surgery or cataract surgery, preoperative refractive error demonstrating more than 8 diopters), or axial length >26.5 mm when reliable refractive assessment is unavailable;
- Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as IOP≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye;
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 |
|---|---|---|
| GB10GB10 Intravitreal Injection with indicating dosage. | Drug | MAD Dose 1, MAD Dose 2, SAD Dose 1, SAD Dose 2, SAD Dose 3, SAD Dose 4, SAD Dose 5, SAD Dose 6 |
Primary outcome
The incidence and severity of ocular adverse events
Time frame: From enrollment to the end of treatment at 12 weeks
The incidence and severity of non-ocular adverse events
Time frame: From enrollment to the end of treatment at 12 weeks
(SAD) The change in best corrected visual acuity (BCVA) from baseline after 4 weeks of treatment
Time frame: From enrollment to the end of treatment at 4 weeks
(MAD) The change in best corrected visual acuity (BCVA) from baseline after 12 weeks of treatment
Time frame: From enrollment to the end of treatment at 12 weeks
12 secondary outcomes
(SAD) Change in central retinal subfield thickness (CST) from baseline at 4 weeks of treatment
Time frame: From enrollment to the end of treatment at 4 weeks
(MAD) Change in central retinal subfield thickness (CST) from baseline at 12 weeks of treatment
Time frame: From enrollment to the end of treatment at 12 weeks
Time of receiving rescue therapy for nAMD activity
Time frame: From enrollment to the end of treatment at 12 weeks
Positive rate of anti-drug antibody and neutralizing antibody of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
Area under the drug-time curve from 0 to time t of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
Area under the curve at the time of 0-infinity of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
Peak concentration of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
Peak time of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
Clearance rate of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
Half-life of GB10
Time frame: From enrollment to the end of treatment at 12 weeks
VEGF concentration
Time frame: From enrollment to the end of treatment at 12 weeks
Ang2 concentration
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB10 in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 6 sites 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 9 inclusion and 25 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hengxin Peng (86-0755-23018589, penghengxin@kexing.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of ocular adverse events (time frame: From enrollment to the end of treatment at 12 weeks). 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?
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 12 Feb 2026.