Clinical trial NCT05940428: A Study of ASKG712 in Patients With Diabetic Macular Edema
Official title: A Multicenter, Non-Randomized, Open-Label, Multiple-Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Diabetic Macular Edema
Lead sponsor: AskGene Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Suzhou Aosaikang Biopharmaceutical Co., Ltd.
First posted: 2023-07-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, non-randomized, open-label, multiple-dose-escalation and dose-expansion study will investigate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 following intravitreal administration in patients with diabetic macular edema (DME).

Detailed description: The Part 1 of study is a multicenter, open-label, sequentially, multiple-dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Patients will be sequentially enrolled into four different dose-level cohorts following accelerated titration combined with the traditional "3+3" design.

The Part 2 of study is a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME.

Eligibility criteria: Inclusion Criteria:

1. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
2. Hemoglobin A1c of less than or equal to 12%
3. For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment
4. Ability and willingness to undertake all scheduled visits and assessments
5. Macular thickening secondary to DME involving the center of the fovea
6. Decreased visual acuity attributable primarily to DME

Exclusion Criteria:

1. History of allergy or current allergic response to ASKG712 or fluorescein
2. Diseases that affect intravenous injection and venous blood sampling
3. Uncontrolled blood pressure
4. Systemic autoimmune diseases
5. Previous anti-VEGF drug treatment
6. Currently pregnant or breastfeeding, or intend to become pregnant during the study
7. Any uncontrolled clinical disorders
8. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
9. History of intraocular or periocular corticosteroid treatment in the study eye
10. Uncontrolled previous or current glaucoma in the study eye
11. Previous intraocular operations in the study eye
12. Active intraocular or periocular infection or active intraocular inflammation in the study eye
13. History of uveitis in either eye
14. Other protocol-specified inclusion/exclusion criteria may apply

Primary outcomes:
measure: 1. Incidence of ocular adverse events (AEs) of the study eyes
timeFrame: 24 weeks
measure: 2. Incidence of non-ocular AEs
timeFrame: 24 weeks
Secondary outcomes:
measure: 1. Area under the concentration time curve (AUC)
timeFrame: 24 weeks
measure: 2. Maximum plasma concentration (Cmax)
timeFrame: 24 weeks
measure: 3. Incidence of Anti-Drug Antibody (ADA)
timeFrame: 24 weeks
measure: 4. Change From Baseline in BCVA in the Study Eye Over Time
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Peking Union Medical College Hospital
name: Youxin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: