Clinical Study of the Safety and Efficacy of BAT5906 Injection

NCT04772105 | Completed Phase 1

• 1 other identifier: BAT5906-003-CR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 19

Brief Summary

This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the efficacy and safety of BAT5906 injection in patients with diabetic macular edema. BAT5906's phase I study on w-AMD shows that it is safe from 0.3-4.0 mg, and the higher dose (2.5 mg and 4 mg) may maintain the effect for longer; the same target drugs (such as brolucizumab and Abecip ) It has also been found in clinical studies that high doses can extend the dosing interval and reduce the dosing frequency. Therefore, in this study, two safe and effective doses were selected, and the optimal clinical effective dose and frequency of BAT5906 in DME were initially explored.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (12)

• Vital signs（ body temperature）

  the patient's body temperature (axillary temperature) Any clinically significant abnormality should be reported as an adverse event and recorded in the original

  After patient resting for more than 3 minutes

• Vital signs（heart rate/pulse）

  heart rate/pulse Any clinically significant abnormality should be reported as an adverse event and recorded in the original

  After patient resting for more than 3 minutes

• Vital signs（respiratory rate）

  respiratory rate Any clinically significant abnormality should be reported as an adverse event and recorded in the original

  After patient resting for more than 3 minutes

• Vital signs（blood pressure）

  blood pressure Any clinically significant abnormality should be reported as an adverse event and recorded in the original

  After patient resting for more than 3 minutes

• physical examination

  Physical examination should include at least general conditions, head and face, skin, lymph nodes, ears, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and spleen), genitourinary system, musculoskeletal system, nervous system, and mental condition

  The investigator or other authorized and qualified investigator shall perform the prescribed physical examination according to the evaluation schedule. During the visit, the investigator performed a physical examination as indicated by symptoms

• laboratory examination（blood routine）

  In the test process will be carried out in accordance with the testing program flow chart of blood routine, the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record

  Screening period，Week 12, Week 24, Week 48 of the last visit

• laboratory examination（outine urine）

  In the test process will be carried out in accordance with the testing program flow chart of routine urine , the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record

  Screening period，Week 12, Week 24, Week 48 of the last visit

• laboratory examination（blood biochemical examination）

  In the test process will be carried out in accordance with the testing program flow chart of blood biochemical examination, the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record

  Screening period，Week 12, Week 24, Week 48 of the last visit

• laboratory examination（blood coagulation function）

  In the test process will be carried out in accordance with the testing program flow chart of blood coagulation function, the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record

  Screening period，Week 12, Week 24, Week 48 of the last visit

• electrocardiogram（12- Lead ECG）

  During the trial, the examination of the electrocardiogram (ecg) method must be consistent, and to evaluate the clinical significance of the results, will any researchers to make judgment for clinical significance of abnormal as adverse events were reported, and recorded in the original records and case report form, the subjects in the process of the entire study if there is clinical indications by researchers to determine whether the need for ecg examination.

  Screening period of the first visit: Week 12 of the fifth visit, Week 24 of the eighth visit, and Week 48 of the last visit

• anti-drug antibody (ADA)

  Plasma samples for anti-drug antibody (ADA) detection were collected to detect the positive incidence of ADA associated with plasma levels of BAT5906

  24 hours before 1, 2, 3, 4 dosing, 5 dosing to last visit, each dosing before and 24 hours before the last visit as needed

• ocular and non-ocular adverse events (AE) and serious adverse events (SAE)

  Any adverse medical event that occurs after a subject participates in a clinical trial and receives the investigational drug, but is not necessarily cause-and-effect with the treatment. An adverse event can be any adverse or unexpected sign (including abnormal laboratory tests), symptom, or disease, whether or not it is drug related.

  Adverse events were collected from the time the patient signed the informed consent to the time 28 days after the last dication

Secondary Outcomes (5)

• Effectiveness evaluation

  Week 24

• Effectiveness evaluation

  Week 12 and 48

• Effectiveness evaluation

  at weeks 12, 24, and 48

• Effectiveness evaluation

  at weeks 12, 24, and 48

• Effectiveness evaluation

  24 weeks and 48 weeks

Other Outcomes (3)

• Pharmacokinetic (PK) evaluation

  Once within 24 hours before administration.6 hours after administration, 24 hours after administration (once every 3 days) up to 672 hours after administration

• Peripheral blood VEGF evaluation (VEGF)

  Once within 24 hours before administration.24 hours after administration (once every 7 days) up to 672 hours after administration

• Evaluation of immunogenicity

  First administration: within 24 hours prior to administration.168 hours and 336 hours after administration, and the second until the last administration: within 24 hours before administration

Study Arms (2)

2.5mg of BAT5906

EXPERIMENTAL

Specification: 10mg/0.2ml/piece; route of administration: intravitreal injection; dose: 2.5mg/eye/time, 50μl; medication duration: once every 4 weeks, 6 consecutive times, then every 4 weeks Followed up once (the investigator judged to administer the drug as needed) and observed until the 48th week.

Drug: 2.5mg of BAT5906

4mg of BAT5906

EXPERIMENTAL

Specification: 16mg/0.2ml/piece; route of administration: intravitreal injection; dose: 4mg/eye/time, 50μl; medication duration: once every 4 weeks, 3 consecutive times, then every 4 weeks Followed up once (the investigator judged to administer the drug as needed) and observed until the 48th week.

Drug: 4.0mg of BAT5906

Interventions

2.5mg of BAT5906 DRUG

Specification: 2.5mg of BAT5906

2.5mg of BAT5906

4.0mg of BAT5906 DRUG

Specification: 4.0mg of BAT5906

4mg of BAT5906

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only the following criteria are met:
• Sign the informed consent voluntarily, willing and capable to follow the procedures of outpatient visits and research at the time specified in the trial
• Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years old;
• The drug treatment to control diabetes must be stable within 3 months before randomization and is expected to remain stable during the study period;
• Macular edema secondary to diabetes, and found to be involved in the macular center (fovea) of the research eye by OCT examination, confirmed by the reading center during screening;
• The CRT of the research eye evaluated by OCT examination is ≥300 μM, confirmed by the reading center during screening;
• The BCVA of the research eye is 73-24 letters (using the ETDRS table, including the boundary value, which is equivalent to the Snellen visual acuity score of the research eye equal to 20/40 -20/400);
• At the time of screening and baseline, the investigator judged that the contralateral eye was expected to not require any anti-VEGF treatment within 3 months (PK group only).

You may not qualify if:

• If a patient meets any of the following conditions, they cannot enter the study:
• There is structural damage to the center of the macula in the eye, and the best corrected vision may not be improved after the macular edema resolves, including atrophy of retinal pigment epithelial cells, subretinal fibrosis or scarring, and obvious macular ischemia (FFA suggests arching Obvious damage), macular anterior membrane involving fovea or organic hard exudate (as confirmed by the reading center before randomization);
• The research eye has iris lesions and neovascular glaucoma;
• Those who have no eye lens (except intraocular lens);
• The study eye has active hyperplastic diabetic retinopathy (PDR);
• The research eye has anyone other than diabetic macular edema that may confuse macular assessment or vision testing (retinal vascular occlusion, retinal detachment, vitreous macular traction, macular hole, preretinal fibrosis involving the macula, choroidal neovascularization, age Related macular degeneration, etc.);
• The research eye is accompanied by poorly controlled glaucoma, which is defined as the intraocular pressure still ≥21mmHg after treatment with anti-glaucoma drugs, or according to the judgment of the investigator;
• The research eye has undergone or may have undergone anti-glaucoma surgery during the study period (including trabeculectomy, sclerectomy and non-penetrating trabecular surgery, etc.);
• The research eye has undergone vitreoretinal surgery or scleral buckling;
• At the time of screening and baseline, the study eye had received laser photocoagulation (total retina or macular laser photocoagulation) within 90 days (including 90 days) or during the study period;
• At the time of screening and baseline, the study eye had any intraocular or perocular surgery within 90 days (including 90 days) (except for yttrium-aluminum-garnet (YAG) lens capsule incision and eyelid surgery for more than 30 days) ;
• A history of uveitis in any eye;
• Any eye has active ocular inflammation or infection (bacterial, viral, parasitic or fungal infection);
• At the time of screening and baseline, any eye had received intraocular anti-VEGF treatment within the first 90 days (including 90 days), such as ranibizumab, bevacizumab, abercept, compacept, etc.;
• At the time of screening and baseline, any eye has received intraocular, periocular, and subconjunctival corticosteroid treatment within the first 90 days (including 90 days);

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (19)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijiang, Beijing Municipality, 100730, China

Location

Eye Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Henan Provincial Eye Hospital

Henan, China

Location

Jieyang People's Hospital

Jieyang, China

Location

The First Hospital of Jilin University

Jilin, China

Location

The Affiliated Eye Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China

Location

Affiliated Hospital of Nantong University

Nantong, China

Location

Affiliated Hospital of Qingdao University

Qingdao, China

Location

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, China

Location

West China Hospital of Sichuan University

Sichuan, China

Location

Wenzhou Medical University Affiliated Optometry Hospital

Wenzhou, China

Location

The Second Xiangya Hospital of Central South University

Xiangya, China

Location

Xiangya Hospital Central South University

Xiangya, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Study Officials

• Youxin Chen

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: one investigational medicine with two different dose groups

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: February 26, 2021
• Study Start: October 16, 2020
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (19)