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Neovascular Age-related Macular DegenerationPhase 1NCT02613559

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

A Phase 1 study testing TK001 in people with Neovascular Age-related Macular Degeneration, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
What is being tested?
TK001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
Nov 2015to Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • PLT≤100×109/L, BUN, Cr, thrombin time and prothrombin time beyond the upper limit of the normal range; take anti-platelet aggregation drugs within a month prior to enrollment
  • With surgery within one month prior to enrollment, or with unhealing wound, ulcer, fracture at present
  • Diabetic patients without the control of glucose or accompanied by diabetic retinopathy
  • With a history of myocardial infarction within 6 months before enrolled
  • With activity disseminated intravascular coagulation and a tendency of significant bleeding prior to enrollment
  • Systemic autoimmune disease
  • Any uncontrolled clinical problems (such as severe systemic diseases of mental, neurological, cardiovascular, respiratory and malignancies)
  • Pregnant and lactating women and patients who cannot take contraceptive measures
  • Poor compliance
  • The patients who is considered unsuitable for enrollment by investigator

Trial locations and contacts

1 site in 1 country.

Guangfu Li contact

guangfuli@t-mab.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

    Ming Zhang

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Open-label, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Tolerability of Intravitreal TK001(Recombinant Humanized Anti-VEGF Monoclonal Antibody) in Subjects With Neovascular Age-Related Macular Degeneration

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.

Read the detailed description

This is an open-label, non-comparative, non-randomized, single-center phase 1 study evaluating pharmacokinetics, safety and tolerability of single intravitreal injections of TK001 in the patients with AMD.TK001 is a full-length recombinant humanized anti-VEGF monoclonal antibody. Compared with Avastin(a similar marketed product), the findings of preclinical studies suggested that TK001 might be more effective in inhibiting pathological angiogenesis, or to achieve equivalent effect with less dosage and better safety. In this study, participants will be administrated a single dose of TK001.Every subject will only accept one dose. In addition to safety and preliminary efficacy, pharmacokinetics and immunogenicity of TK001will be evaluated as well.

Being tested
TK001
Keywords
Neovascular Age-Related Macular Degeneration, Subfoveal CNV, TK001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TK001Biological

    Intravitreal Injection

Study groups in NCT02613559
Study groupRoleWhat they receive
TK001 0.1mgExperimentalInjection:single Intravitreal Injection
Receives: Biological: TK001
TK001 0.5mgExperimentalInjection:single Intravitreal Injection
Receives: Biological: TK001
TK001 1.0mgExperimentalInjection:single Intravitreal Injection
Receives: Biological: TK001
TK001 2.0mgExperimentalBiological: TK001 Injection:single Intravitreal Injection
Receives: Biological: TK001
TK001 2.5mgExperimentalBiological: TK001 Injection:single Intravitreal Injection
Receives: Biological: TK001
TK001 3.0mgExperimentalInjection:single Intravitreal Injection
Receives: Biological: TK001

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 weeks

Secondary outcomes (6)

  1. Best Corrected Visual Acuity (BCVA)

    Measured: 6 weeks

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

    Measured: Up to Day 42

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

    Measured: Up to Day 42

  4. Maximum observed maximum plasma concentration (Cmax)

    Measured: Up to Day 42

  5. Time to reach the maximum observed plasma concentration (Tmax)

    Measured: Up to Day 42

  6. Frequency of subjects with anti-TK001 antibody

    Anti- TK001 antibody will be detected pre-dose,14d and 42d.

    Measured: Up to Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJun 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613559
Sponsor's protocol ID
Tmab-TK001-AMD-01
Status last verified
Feb 2018
First submitted
21 Nov 2015
Last updated
1 Mar 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TK001 in people with Neovascular Age-related Macular Degeneration, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guangfu Li (guangfuli@t-mab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.

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