Evaluation the Pharmacokinetics, Safety, Tolerability of TK001 in Patients With Neovascular Age-related Macular Degeneration

NCT02613559 | Unknown Phase 1

• 1 other identifier: Tmab-TK001-AMD-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and tolerability of single ascending doses of TK001(Recombinant humanized anti-VEGF monoclonal antibody) to determine the maximum tolerated dose (MTD) in neovascular wet age-related macular degeneration (wAMD) subjects.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration, Subfoveal CNV, TK001

Outcome Measures

Primary Outcomes (1)

• Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001

  6 weeks

Secondary Outcomes (6)

• Best Corrected Visual Acuity (BCVA)

  6 weeks

• Area under the plasma concentration-time curve from time zero to infinity (AUCinf)

  Up to Day 42

• Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t)

  Up to Day 42

• Maximum observed maximum plasma concentration (Cmax)

  Up to Day 42

• Time to reach the maximum observed plasma concentration (Tmax)

  Up to Day 42

Study Arms (6)

TK001 0.1mg

EXPERIMENTAL

Injection:single Intravitreal Injection

Biological: TK001

TK001 0.5mg

EXPERIMENTAL

Injection:single Intravitreal Injection

Biological: TK001

TK001 1.0mg

EXPERIMENTAL

Injection:single Intravitreal Injection

Biological: TK001

TK001 2.0mg

EXPERIMENTAL

Biological: TK001 Injection:single Intravitreal Injection

Biological: TK001

TK001 2.5mg

EXPERIMENTAL

Biological: TK001 Injection:single Intravitreal Injection

Biological: TK001

TK001 3.0mg

EXPERIMENTAL

Injection:single Intravitreal Injection

Biological: TK001

Interventions

TK001 BIOLOGICAL

Intravitreal Injection

TK001 0.1mg; TK001 0.5mg; TK001 1.0mg; TK001 2.0mg; TK001 2.5mg; TK001 3.0mg

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their legal representative signed informed consent
• Aged 45 years to 80 years, male or female
• Inpatient/Outpatient with confirmed neovascular AMD
• Best corrected VA for the studied eye≤20/100
• With primary or recurrent subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
• Blood pressure is stable with SBP\<140 mmHg and DBP\<90 mmHg with or without treatment

You may not qualify if:

• Limitation of eye diseases
• The studied eye suffered intravitreal blood within two months prior to screening
• The studied eye suffered structural damage of retinal which involved macular center(such as epiretinal membrane, scars, laser burns, foveal atrophy, dense pigment changes, intensive subfoveal hard exudates)
• Apparent cataract, aphakia, pseudoexfoliation syndrome, intraocular hemorrhage resulting in decreased vision, rhegmatogenous retinal detachment, macular hole, diabetic retinopathy and diabetic macular disease which need to be treated, choroidal neovascularization (CNV) for any reason except for AMD (such as ocular histoplasmosis, pathologic myopia)
• Afferent pupillary defect(APD)
• Refractive media opacity and miosis which effect fundus examination
• Any eye of patient with active inflammation, such as conjunctivitis, keratitis, scleritis, uveitis and endophthalmitis
• Choroidal neovascularization (CNV) for other reason, such as diabetic retinopathy, fundus angioid streaks, ocular histoplasmosis, pathologic myopia, trauma
• The treatment of the eye
• The studied eye received topical or grid photocoagulation more than twice or within 3 months before screening
• The studied eye received any intraocular surgery or laser treatment (such as macular translocation surgery, glaucoma filtering surgery, verteporfin photodynamic therapy, transpupillary thermotherapy, foveal photocoagulation surgery, cataract surgery, vitreous cutting surgery, optic nerve incision operation, YAG posterior capsular incision surgery, sheath incision surgery or filtering surgery) within 3 months before screening
• Any eye received antiangiogenic drugs (including any anti-VEGF drugs) (such as pegaptanib \[Macugen®\], Aflibercept \[Eylea®\], ranibizumab \[Lucentis ®\], bevacizumab \[Avastin ®\]) within 3 months before baseline visit
• Any eye received intraocular injection of corticosteroid drugs (such as triamcinolone acetonide), or periocular injection of corticosteroid drugs within 1 months before screening
• Systemic diseases,treatment and other conditions
• With a history of allergy to sodium fluorescein and indocyanine green

Sponsors & Collaborators

• Jiangsu T-Mab Biopharma Co.,Ltd: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Study Officials

• Ming Zhang

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangfu Li

CONTACT

guangfuli@t-mab.com

Study Design

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

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

CN (1)