A Study of ASKG712 in Patients With Diabetic Macular Edema

• Sponsor: AskGene Pharma, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05940428
• Collaborator: Suzhou Aosaikang Biopharmaceutical Co., Ltd. (Other)
• Enrollment: 26
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Biological: ASKG712	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 30, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASKG712 Multiple doses of ASKG712 by intravitreal injection	Biological: 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.; Other Names: AM712

Outcome Measures

Primary Outcome Measures

1. 1. Incidence of ocular adverse events (AEs) of the study eyes [24 weeks]

   Any relevant ocular observations derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography

2. 2. Incidence of non-ocular AEs [24 weeks]

   Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests

Secondary Outcome Measures

1. 1. Area under the concentration time curve (AUC) [24 weeks]

   To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME

2. 2. Maximum plasma concentration (Cmax) [24 weeks]

   To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME

3. 3. Incidence of Anti-Drug Antibody (ADA) [24 weeks]

   To evaluate the immunogenicity of ASKG712 in patients with DME

4. 4. Change From Baseline in BCVA in the Study Eye Over Time [24 weeks]

   To evaluate the efficacy of ASKG712 in patients with DME

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing		China

Sponsors and Collaborators

• AskGene Pharma, Inc.
• Suzhou Aosaikang Biopharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Youxin Chen, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AskGene Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT05940428
• Other Study ID Numbers: ASKG712-CT-I-2
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 14, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Edema

Study Results

No Results Posted as of Jul 14, 2023