A Phase I Clinical Trial of BAT5906 Injection in Patients With Wet Age-related Macular Degeneration

NCT04151212 | Completed Phase 1

• 1 other identifier: BAT5906-001-CR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (7)

• Dose-limiting toxicity(DLT)

  Safety and tolerability endpoint

  2 weeks

• Maximum tolerated dosed(MTD)

  Safety and tolerability endpoint

  0-70days

• Area under the curve(AUC0-t, AUC0-inf)

  Pharmacokinetic endpoint Pharmacokinetic endpoint

  0-70days

• Maximum serum drug concentration(Cmax)

  Pharmacokinetic endpoint Pharmacokinetic endpoint

  0-70days

• Half-life period(t1/2)

  Pharmacokinetic endpoint

  0-70days

• Maximum serum drug time(Tmax)

  Pharmacokinetic endpoint

  0-70days

• Plasma clearance(CL)

  Pharmacokinetic endpoint

  0-70days

Secondary Outcomes (4)

• Anti-drug antibodies(ADA)

  0-70days

• Best correct vision(BCVA)

  0-70days

• Central Retinal thickness(CRT)

  0-70days

• VEGF concentration

  0-70days

Study Arms (1)

BAT5906 injection

EXPERIMENTAL

Single dose escalation starting from 0.3mg. Route of administration: intravitreal injection.

Drug: BAT5906 injection

Interventions

BAT5906 injection DRUG

Signal dose escalation starting from 0.3mg. Route of administration: intravitreal injection

Also known as: No Other Intervention Names

BAT5906 injection

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 50-80 years old .
• Signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
• Best corrected visual acuity ≥34 Early Treatment of Diabetic Retinopathy Study letters (≥20/200) . in the non-study eye.

You may not qualify if:

• There are atrophy of the ground pattern involving the fovea, scar or fibrosis, macular anterior membrane, rigid exudation under dense fovea, RPE tear in the study eye.
• Retinal hemorrhage ≥4 disc area in the study eye.
• Dioptric media turbid or the pupil cannot be dilated were significant interference with the detection of vision, the evaluation of the anterior segment and fundus in the study eye.
• Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g.,Retinal vein occlusion, uveitis, vascular striatum, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease etc).
• History of vitrectomy surgery\\macular transposition\\glaucoma filtration in the study eye.
• Photodynamic therapy(PDT), in macular area laser photocoagulation therapy, transpermary hyperthermia(TTT), and other operations for AMD within 3 months prior to screening visit in the study eye.
• History of extraocula surgeryr within 1 months or cataract surgery within 3 months prior to screening visit in the study eye.
• Aphakia(exclusive of intraocular lens) or rupture of posterior capsule( within1 months prior to the YAG laser retrovesiculotomy (after the artificial crystal), was excluded) in the study eye.
• APD in the study eye or pseudocyst stripping syndrome in either eye.
• Intravitrea or Systemicl anti-VEGF injection (ranibizumab, aflibercept, bevacizumab or Conbercept etc) in either eye within 3 months prior to screening visit.
• Under the conjunctiva,intravitreal or periocular corticosteroid, within 3 months prior to screening visit in either eye.
• vitreous hemorrhage within 3 months prior to screening Visit in either eye.
• Ocular or periocular infection in either eye.
• History of glaucoma in either eye.
• Visudyne (verteporfin) photodynamic therapy within 1 months prior to screening Visit in non-study eye.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Youxin Chen

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 5, 2019
• Study Start: October 30, 2018
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: September 23, 2021

Record last verified: 2019-10

Locations

CN (1)