Healthy VolunteersEarly Phase 1NCT03795142
A First-time-in-human Study of BGB149
A Early Phase 1 study testing BGB149 in people with Healthy Volunteers, run by BerGenBio ASA at 1 site in United Kingdom.
Trial summary
This clinical trial is a Phase I, first-in-human. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of BGB149 after single IV doses in healthy male and female subjects. Multiple dose levels will be explored. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BGB149
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2018to 31 Oct 2019
- Phase
- Early 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee approved informed consent form prior to performing any of the screening procedures.
- Healthy male and female subjects, between 18 to 55 years of age, inclusive, at the screening visit.
- If male, Must agree to use appropriate double-barrier contraception and to refrain from donating sperm from the time of dosing until 3 months after dosing.
- If female, Must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year with follicle stimulating hormone > 40 IU/L).
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit with a weight of at least 50kg.
- Non-smoker, defined as a subject who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products (including snuff and similar products) at least 3 months before the screening visit.
- Subjects are in good health, as determined by medical history, physical examination, vital signs assessment, resting 12-lead ECG and clinical laboratory evaluations within normal reference ranges or outside of normal reference ranges considered not clinically relevant by the Principal Investigator or designee.
- Subject must have suitable veins for cannulation and/or repeated venipuncture.
Who cannot join
- Female subjects of childbearing potential, or breastfeeding, or have a positive serum pregnancy test at the screening visit or a positive urine pregnancy test on admission.
- A positive urine cotinine result (>500ng/mL) at the screening visit or on admission.
- Subjects who have ongoing or significant history of alcoholism or drug/chemical abuse in the past 5years, as determined by the Principal Investigator or designee.
- Subjects who have positive urine drugs of abuse screen at the screening visit or on admission, or a positive urine alcohol test at the screening visit or on admission.
- Subjects who are unwilling to avoid the use of alcohol within 48 hours before any study visit and while confined to the study center.
- Subjects who are unwilling to abstain from heavy physical training from 7 days before first dosing until the final follow-up visit.
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- Subjects who have used the following: Any prescribed medication within 14 days prior to planned time of dosing. Non-prescription or over-the-counter medication, herbal and dietary supplements such as St John's Wort, vitamins and minerals that could affect the outcome of the study within 1 week prior to planned time of dosing. Live attenuated vaccines and systemic corticosteroids within 3 months prior to planned time of dosing.
- Subjects who have donated blood in the 3 months prior to the screening visit, plasma in the 7 days prior to the screening visit or platelets in the 6 weeks prior to the screening visit.
- Subjects who have a history of significant drug allergy (e.g., anaphylaxis) or any clinically significant allergic condition (excluding non-active hay fever), as determined by the Principal Investigator or designee.
- Subjects who have had a clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing, as determined by the Principal Investigator or designee.
- Subjects with history of gastrointestinal bleeding or ulceration or perforation; history of Crohn's disease or any other inflammatory disorder of the gastrointestinal tract.
- Subjects with history of bone marrow transplant, with or without graft versus host disease.
- Subjects who have pulse, blood pressure, respiratory rate or oral body temperature values outside the normal ranges at the screening visit or on admission that is, in the opinion of the Principal Investigator or designee, clinically relevant and increases the risk of participating in the study.
- Results of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and/or total bilirubin (TBL) above the upper limit of normal (ULN), as confirmed by subsequent repeat assessment, at the screening visit and on admission.
- A positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or antibodies to human immunodeficiency virus (HIV) Type 1 and/or Type 2 at the screening visit.
- Subjects who are still participating in another clinical study or received last study drug dose in a clinical study within 3 months or 5 half-lives, prior to dosing in this study, whichever is longer.
- Employees of the Sponsor or the contract research organization (CRO), with direct involvement in the proposed study or other studies under the direction of the Principal Investigator or the CRO, as well as close relatives of the employees.
- Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
- Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Parexel Northwick Park
London, Harrow, Middlesex, HA1 3UJ
About this study
Official title: A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BGB149 Following Single Dose Administration in Healthy Subjects
This clinical trial is a Phase I, first-in-human. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of BGB149 after single IV doses in healthy male and female subjects. Multiple dose levels will be explored.
- Conditions
- Healthy Volunteers
- Being tested
- BGB149, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB149Biological
Single Ascending Dose
PlaceboBiological
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| single intravenous dose; BGB149 | Experimental | A single intravenous dose of BGB 149 or matched placebo will be administered on day 1 ascending doses will be administered in cohorts of 6 (randomised 4:2, active: placebo) at a planned four dose levels (maximum of six dose levels to be investigated under initial approved protocol) A sentinel cohort of 2 volunteers will randomly receive (1:1) either experimental or matched placebo infusion Receives: Biological: BGB149 |
| single intravenous dose; placebo | Placebo comparator | A single intravenous dose of BGB 149 or matched placebo will be administered on day 1 ascending doses will be administered in cohorts of 6 (randomised 4:2, active: placebo) at a planned four dose levels (maximum of six dose levels to be investigated under initial approved protocol) A sentinel cohort of 2 volunteers will randomly receive (1:1) either experimental or matched placebo infusion Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent clinical adverse events (AE) following single intravenous (IV) administration of BGB149 or matched placebo
Number of healthy volunteers experiencing adverse events (AE) AE categorized by grading for severity according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0).
Measured: 85 days
Frequency of treatment-emergent laboratory abnormalities following single intravenous (IV) administration of BGB149 or matched placebo
Number of healthy volunteers experiencing clinically significant abnormalities of clinical laboratory tests (hematology, coagulation, clinical chemistry and urinalysis); categorized by grading for severity according to the CTCAE version 5.0.
Measured: 85 days
Secondary outcomes (10)
Pharmacokinetic Parameters: BGB149 Cmax following single intravenous (IV) administration of BGB149 or matched placebo
Cmax: measured maximum BGB149 concentration, determined directly from the concentration-time profile.
Measured: 85 days
Pharmacokinetic Parameters: BGB149 Tmax following single intravenous (IV) administration of BGB149 or matched placebo
Tmax: Time of maximum BGB149 concentration determined directly from the concentration-time profile.
Measured: 85 days
Pharmacokinetic Parameters: BGB149 AUC(0-last), following single intravenous (IV) administration of BGB149 or matched placebo
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration calculated using the linear-log trapezoidal rule.
Measured: up to 85 days
Pharmacokinetic Parameters: BGB149 AUC(0-infinity) following single intravenous (IV) administration of BGB149 or matched placebo
Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUClast + Clast/Lambda[z]) calculated using the linear-log trapezoidal rule.
Measured: 85 days
Pharmacokinetic Parameters: BGB149 terminal elimination rate constant λz, following single intravenous (IV) administration of BGB149 or matched placebo
λz: The terminal elimination rate constant determined by selection of at least three data points on the terminal phase of the concentration-time curve.
Measured: 85 days
Pharmacokinetic Parameters: BGB149 t½: Terminal elimination half-life, following single intravenous (IV) administration of BGB149 or matched placebo
t½: Terminal elimination half-life calculated as: ln2/λz
Measured: 85 days
Pharmacokinetic Parameters: BGB149 total body clearance (CL) following single intravenous (IV) administration of BGB149 or matched placebo
CL: Total body clearance
Measured: 85 days
Immunogenicity indicators: anti-drug antibodies [ADA]
Immunogenicity - Detection and titre of anti-drug antibodies [ADA], determined using a validated assay.
Measured: 85 days
Immunogenicity indicators: neutralizing antibodies [NAb]
Immunogenicity - Detection and titre of neutralizing antibodies [NAb], determined using a validated assay (titres and NAb analyses performed when ADA screening is positive
Measured: 85 days
Pharmacodynamics: detection of soluble Axl protein in circulation
PD - Concentration of soluble Axl measured in serum after dosing, determined using a validated assay.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start19 Dec 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- BerGenBio ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795142
- Sponsor's protocol ID
- BGB149-101
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BGB149 Following Single Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03795142
- Acronym / sponsor ID
- BGB149-101
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BerGenBio ASAIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 7 Jan 2019 (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 clinical trial is a Phase I, first-in-human. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of BGB149 after single IV doses in healthy male and female subjects. Multiple dose levels will be explored.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single intravenous dose; BGB149 | Experimental | Biological: BGB149A single intravenous dose of BGB 149 or matched placebo will be administered on day 1 ascending doses will be administered in cohorts of 6 (randomised 4:2, active: placebo) at a planned four dose levels (maximum of six dose levels to be investigated under initial approved protocol) A sentinel cohort of 2 volunteers will randomly receive (1:1) either experimental or matched placebo infusion |
| single intravenous dose; placebo | Placebo comparator | Biological: PlaceboA single intravenous dose of BGB 149 or matched placebo will be administered on day 1 ascending doses will be administered in cohorts of 6 (randomised 4:2, active: placebo) at a planned four dose levels (maximum of six dose levels to be investigated under initial approved protocol) A sentinel cohort of 2 volunteers will randomly receive (1:1) either experimental or matched placebo infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee approved informed consent form prior to performing any of the screening procedures.
- Healthy male and female subjects, between 18 to 55 years of age, inclusive, at the screening visit.
- If male, Must agree to use appropriate double-barrier contraception and to refrain from donating sperm from the time of dosing until 3 months after dosing.
- If female, Must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year with follicle stimulating hormone > 40 IU/L).
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit with a weight of at least 50kg.
Key exclusion criteria (19 listed)
- Female subjects of childbearing potential, or breastfeeding, or have a positive serum pregnancy test at the screening visit or a positive urine pregnancy test on admission.
- A positive urine cotinine result (>500ng/mL) at the screening visit or on admission.
- Subjects who have ongoing or significant history of alcoholism or drug/chemical abuse in the past 5years, as determined by the Principal Investigator or designee.
- Subjects who have positive urine drugs of abuse screen at the screening visit or on admission, or a positive urine alcohol test at the screening visit or on admission.
- Subjects who are unwilling to avoid the use of alcohol within 48 hours before any study visit and while confined to the study center.
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 |
|---|---|---|
| BGB149Single Ascending Dose | Biological | single intravenous dose; BGB149 |
| PlaceboMatching placebo | Biological | single intravenous dose; placebo |
Primary outcome
Incidence of treatment-emergent clinical adverse events (AE) following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Number of healthy volunteers experiencing adverse events (AE) AE categorized by grading for severity according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0).
Frequency of treatment-emergent laboratory abnormalities following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Number of healthy volunteers experiencing clinically significant abnormalities of clinical laboratory tests (hematology, coagulation, clinical chemistry and urinalysis); categorized by grading for severity according to the CTCAE version 5.0.
10 secondary outcomes
Pharmacokinetic Parameters: BGB149 Cmax following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Pharmacokinetic Parameters: BGB149 Tmax following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Pharmacokinetic Parameters: BGB149 AUC(0-last), following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: up to 85 days
Pharmacokinetic Parameters: BGB149 AUC(0-infinity) following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Pharmacokinetic Parameters: BGB149 terminal elimination rate constant λz, following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Pharmacokinetic Parameters: BGB149 t½: Terminal elimination half-life, following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Pharmacokinetic Parameters: BGB149 total body clearance (CL) following single intravenous (IV) administration of BGB149 or matched placebo
Time frame: 85 days
Immunogenicity indicators: anti-drug antibodies [ADA]
Time frame: 85 days
Immunogenicity indicators: neutralizing antibodies [NAb]
Time frame: 85 days
Pharmacodynamics: detection of soluble Axl protein in circulation
Time frame: 85 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 16 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Muna Albayaty, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BGB149 in people with Healthy Volunteers, run by BerGenBio ASA at 1 site in United Kingdom.
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 8 inclusion and 19 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 16 Mar 2022. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of treatment-emergent clinical adverse events (AE) following single intravenous (IV) administration of BGB149 or matched placebo (time frame: 85 days). The study lists 2 primary outcomes in all. 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 16 Mar 2022.