Healthy Male SubjectsPhase 1NCT03576651
A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers
A Phase 1 study testing JHL1149 and Bevacizumab in people with Healthy Male Subjects, run by JHL Biotech, Inc. at 1 site in Bulgaria.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- JHL1149 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBulgaria
- Study dates
- 24 Mar 2018to 13 Dec 2019
- 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 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers,
- Age range of 21-55 years (inclusive).
- BMI range of 18.0-30.0 kg/m2 (inclusive) and a total body weight >50 kg.
- Medically healthy subjects with normal organ functions and laboratory values
- Subjects must be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
- 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.
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- Ability and willingness to abstain from alcohol 48hrs prior to admission to the clinical research center, and throughout the dosing and evaluation period.
- No significant medical history per the PI judgment.
- ECGs (via 12 lead) showing normalized cumulative sum (NCS) findings per PI judgment
- Ability to provide informed consent for the study.
Who cannot join
- 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.
- Previous history of cancer other than adequately treated basal cell or squamous cell carcinoma of the skin.
- Received blood transfusions and blood donation within 3 months before screening date.
- Resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg.
- Any other severe physical incapacity.
- 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).
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- 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.
- Major surgery planned for the study duration or cases with major surgery in the past 28 days before screening.
- History of relevant drug and/or food related allergies.
- History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
- History of alcohol and or drug abuse/addiction.
- Positive alcohol breath test and drug screen for opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines.
- Strenuous exercise 96 hrs prior to admission to the clinical research center.
- Any significant or acute illness within 30 days prior to the expected first dose of study drug.
- Unsuitable veins for infusion and/or venepuncture.
- 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.
- Participation in another clinical study where the investigational drug was received within < 5 x half-lives of the drug (120 days prior to screening).
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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) in Healthy Male Volunteers
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
- Conditions
- Healthy Male Subjects
- Being tested
- JHL1149, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JHL1149Biological
Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion
BevacizumabBiological
Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion
BevacizumabBiological
Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| JHL1149 | Experimental | Not described Receives: Biological: JHL1149 |
| US-sourced-Avastin™ | Active comparator | Not described Receives: Biological: Bevacizumab |
| EU-sourced Avastin™ | Active comparator | Not described Receives: Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
area under the concentration-time curve from time zero to infinity (AUC0-inf)
Measured: up to 71 days
Secondary outcomes (2)
AUClast
Area under the serum concentration-time curve from time 0 to last quantifiable concentration (AUClast).
Measured: up to 71 days
Cmax
Maximum serum concentration just prior to end of infusion (Cmax)
Measured: up to 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start24 Mar 2018
- Primary completion17 Sep 2018
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHL Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576651
- Sponsor's protocol ID
- JHL-CLIN-1149-01
- Status last verified
- Jan 2020
- First submitted
- 25 Jun 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03576651
- Acronym / sponsor ID
- JHL-CLIN-1149-01
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- JHL Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JHL1149 | Experimental | Biological: JHL1149 |
| US-sourced-Avastin™ | Active comparator | Biological: Bevacizumab |
| EU-sourced Avastin™ | Active comparator | Biological: Bevacizumab |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male volunteers,
- Age range of 21-55 years (inclusive).
- BMI range of 18.0-30.0 kg/m2 (inclusive) and a total body weight >50 kg.
- Medically healthy subjects with normal organ functions and laboratory values
- Subjects must be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
Key exclusion criteria (18 listed)
- 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.
- Previous history of cancer other than adequately treated basal cell or squamous cell carcinoma of the skin.
- Received blood transfusions and blood donation within 3 months before screening date.
- Resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg.
- Any other severe physical incapacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JHL1149Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion | Biological | JHL1149 |
| BevacizumabEach patient may receive single dose of Avastin 1mg/kg by intravenous infusion | Biological | US-sourced-Avastin™ |
| BevacizumabEach patient may receive single dose of Avastin 1mg/kg by intravenous infusion | Biological | EU-sourced Avastin™ |
Primary outcome
AUC0-inf
Time frame: up to 71 days
area under the concentration-time curve from time zero to infinity (AUC0-inf)
2 secondary outcomes
AUClast
Time frame: up to 71 days
Cmax
Time frame: up to 71 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JHL1149 and Bevacizumab in people with Healthy Male Subjects, run by JHL Biotech, Inc. at 1 site in Bulgaria.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 7 Jan 2020. 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 Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf (time frame: up to 71 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020.