Clinical trial
A Multi-Center, Open-label, Single Ascending-Dose and Multiple Ascending-Dose Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Neovascular Age-related Macular Degeneration
Name
ASKG712-CT-I-1
Description
The purpose of the Phase 1 study is comprised of single ascending-dose component (Part 1) and multiple ascending-dose component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in patients with neovascular age-related macular degeneration (nAMD).
Trial arms
Trial start
2023-02-20
Estimated PCD
2023-12-31
Trial end
2024-04-30
Status
Recruiting
Phase
Early phase I
Treatment
ASKG712
ASKG712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.
Arms:
ASKG712
Other names:
AM712
Size
36
Primary endpoint
Incidence of ocular adverse events (AEs) of the study eyes
Part 1: 6 weeks; Part 2: 20 weeks
Incidence of non-ocular adverse events (AEs)
Part 1: 6 weeks; Part 2: 20 weeks
Eligibility criteria
Inclusion Criteria:
* 1. Signed the informed consent form;
* 2. Male or female subjects with 50\~80 years of age;
* 3. Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesions secondary to neovascular age-related macular degeneration(nAMD);
* 4. Total lesion area ≤ 12 disc area(DA);
* 5. BCVA letter score measured at screening of 19\~78 letters.
Exclusion Criteria:
* 1. History of uveitis in either eye；
* 2. Current active inflammation or infection in the study eye;
* 3. Central foveal scar, fibrosis or atrophy of macular in the study eye;
* 4. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
* 5. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
* 6. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of ASKG712 or require medical or surgical intervention.
* 7. Presence of retinal pigment epithelial tear;
* 8. Previous intraocular operations in the study eye;
* 9. Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
* 10. Previous anti-VEGF drug treatment within 30 days prior to screening；
* 11. Diseases that affect intravenous injection and venous blood sampling;
* 12. Systemic autoimmune diseases;
* 13. Any uncontrolled clinical disorders;
* 14. History of allergy or current allergic response to ASKG712 or fluorescein;
* 15. Pregnant or nursing women;
* 16. Subjects should be excluded in the opinion of investigators.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}
Updated at
2023-03-01
1 organization
1 product
1 indication
Organization
AskGene PharmaProduct
ASKG712Indication
Age-Related Macular Degeneration