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CompletedNCT03576651Updated Jan 7, 2020

A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers

A Phase 1 interventional study of JHL1149 and Bevacizumab in Healthy Male Subjects, sponsored by JHL Biotech, Inc.. Completed at 1 site in Bulgaria. Open to male participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by JHL Biotech, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2018, registered Jun 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
Male
01

Study summary

This is a Phase I, Double-blind, Randomized, Parallel-group, Single-dose, Three-Arm Study to Compare the Pharmacokinetics and to Evaluate the Tolerability, Safety and Immunogenicity of JHL1149 and Bevacizumab (Avastin) Sourced from the European Union (EU) and the Union States (US) in Healthy Male Volunteers

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Conditions studied

  • Healthy Male Subjects
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In context

Lead sponsor

JHL Biotech, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male volunteers,
  2. Age range of 21-55 years (inclusive).
  3. BMI range of 18.0-30.0 kg/m2 (inclusive) and a total body weight >50 kg.
  4. Medically healthy subjects with normal organ functions and laboratory values
  5. Subjects must be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
  6. All intermittent medications including over the counter, herbal and nutriceuticals, must be stopped at least 14 days prior to admission to the clinical research center.
  7. Ability and willingness to abstain from alcohol 48hrs prior to admission to the clinical research center, and throughout the dosing and evaluation period.
  8. No significant medical history per the PI judgment.
  9. ECGs (via 12 lead) showing normalized cumulative sum (NCS) findings per PI judgment
  10. Ability to provide informed consent for the study.

Exclusion criteria

Exclusion Criteria:

  1. Previous treatment with an anti-vascular endothelial growth factor (VEGF) antibody or any other antibody or protein targeting the VEGF receptor or treatment with an immunobiological drug during the last three months.
  2. Previous history of cancer other than adequately treated basal cell or squamous cell carcinoma of the skin.
  3. Received blood transfusions and blood donation within 3 months before screening date.
  4. Resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg.
  5. Any other severe physical incapacity.
  6. Positive serological test for hepatitis B surface antigen or positive antibody for hepatitis C virus or positive antibody for human immunodeficiency virus (type 1 and 2).
  7. Tuberculosis (TB) or an acute systemic infection; demonstrated by positive QuantiFERON-TB and/or Chest radiograph conducted up to 3 months prior or during the screening visit.
  8. Major surgery planned for the study duration or cases with major surgery in the past 28 days before screening.
  9. History of relevant drug and/or food related allergies.
  10. History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
  11. History of alcohol and or drug abuse/addiction.
  12. Positive alcohol breath test and drug screen for opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines.
  13. Strenuous exercise 96 hrs prior to admission to the clinical research center.
  14. Any significant or acute illness within 30 days prior to the expected first dose of study drug.
  15. Unsuitable veins for infusion and/or venepuncture.
  16. History of bleeding disorders, thromboembolic conditions, gastrointestinal perforations or any fistulae, orthostatic hypotension, fainting spells, blackouts for any reasons; as well as presence of a non-healing wound or fracture.
  17. Participation in another clinical study where the investigational drug was received within \< 5 x half-lives of the drug (120 days prior to screening).
  18. Any condition or displayed behaviour that the investigator in their best clinical judgement believes could be detrimental the subject's participation in the study or result in unfavourable outcomes for the subject or study (eg. Clear signs that the patient is withholding information on their substance use/abuse status).
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    JHL1149

    Biological: JHL1149

  • Active comparator
    US-sourced-Avastin™

    Biological: Bevacizumab

  • Active comparator
    EU-sourced Avastin™

    Biological: Bevacizumab

Interventions

  • BiologicalJHL1149

    Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion

  • BiologicalBevacizumab

    Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion

  • BiologicalBevacizumab

    Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion

06

What researchers measure

Primary outcomes

  1. AUC0-inf

    area under the concentration-time curve from time zero to infinity (AUC0-inf)

    Time frame: up to 71 days

Secondary outcomes

  1. AUClast

    Area under the serum concentration-time curve from time 0 to last quantifiable concentration (AUClast).

    Time frame: up to 71 days

  2. Cmax

    Maximum serum concentration just prior to end of infusion (Cmax)

    Time frame: up to 71 days

07

Study locations

1 site
  • MHAT Lyulin EAD
    Sofia, 1336, Bulgaria
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03576651
Lead sponsor
JHL Biotech, Inc.
Responsible party
Sponsor
First posted
Jul 3, 2018
Start date
Mar 24, 2018
Primary completion
Sep 17, 2018
Completion
Dec 13, 2019
Last update
Jan 7, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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