HealthyPhase 1NCT04669262

BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants

A Phase 1 study testing BGB-DXP604 and BGB-DXP593 in people with Healthy, run by BeiGene at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BGB-DXP604 and BGB-DXP593
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteAustralia
Study dates: 9 Dec 2020to 21 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)
Negative SARS-CoV-2 serology test
Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)

Who cannot join

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when receiving the study drug; or interfering with the interpretation of data
Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that has been resected with no evidence of metastatic disease for 3 years
Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study
Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to type 1 diabetes mellitus, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease
Previous receipt of a licensed or investigational biologic agent (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before the randomization
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Q PHARM
Herston, Queensland, 4006

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Subjects

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants

Conditions: Healthy
Being tested: BGB-DXP604, BGB-DXP593, Placebo

What participants receive

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

BGB-DXP604Drug
Administered as intravenous (IV) infusion over 30 to 60 minutes
BGB-DXP593Drug
Administered as intravenous (IV) infusion over 30 to 60 minutes
PlaceboDrug
Placebo to match BGB-DXP593
PlaceboDrug
Placebo to match BGB-DXP604

Study groups in NCT04669262
Study group	Role	What they receive
Part 1: BGB-DXP604	Experimental	Part 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo Receives: Drug: BGB-DXP604; Drug: Placebo
Part 2 : BGB-DXP604 + BGB-DXP593	Experimental	Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo Receives: Drug: BGB-DXP604; Drug: BGB-DXP593; Drug: Placebo

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
A TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline on or after the administration of study drug and up to 30 days after the dose of study drug.
An SAE is any untoward medical occurrence that, at any dose results in death, or is life threatening, or requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect, or is considered a significant medical AE by the investigator based on medical judgment.
Measured: From the day of study drug administration until 30 days after the dose (approximately day 113 )

Secondary outcomes (18)

Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
Measured: From the day of study drug administration until 30 days after the dose (approximately day 113)
Maximum Observed Serum Concentration (Cmax) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/End of Study (EOS)
Maximum Observed Serum Concentration (Cmax) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Half-life Time (t1/2) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Half-life Time (t1/2) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Clearance (CL) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Clearance (CL) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Volume of Distribution (Vz) of BGB-DXP593
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Volume of Distribution (Vz) of BGB-DXP604
Measured: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
Measured: Pre-dose and Days 15,29,57,85 and 113/EOS visit

Timeline

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

9 Dec 202021 May 2021

First posted16 Dec 2020
Study start9 Dec 2020
Primary completion21 May 2021
Study completion21 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by BeiGeneThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04669262
Sponsor's protocol ID: BGB-DXP604-101
Status last verified: Oct 2024
First submitted: 4 Dec 2020
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Subjects
ClinicalTrials.gov ID: NCT04669262
Acronym / sponsor ID: BGB-DXP604-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 9 Dec 2020 (actual)
Primary completion: 21 May 2021 (actual)
Study completion: 21 May 2021 (actual)
First posted: 16 Dec 2020 (actual)
Results: Posted 15 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Part 1: BGB-DXP604	Experimental	Drug: BGB-DXP604, Drug: PlaceboPart 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo
Part 2 : BGB-DXP604 + BGB-DXP593	Experimental	Drug: BGB-DXP604, Drug: BGB-DXP593, Drug: PlaceboSingle dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)
Negative SARS-CoV-2 serology test
Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)

Key exclusion criteria (6 listed)

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when receiving the study drug; or interfering with the interpretation of data
Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that has been resected with no evidence of metastatic disease for 3 years
Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study
Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to type 1 diabetes mellitus, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease
Previous receipt of a licensed or investigational biologic agent (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before the randomization

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
BGB-DXP604Administered as intravenous (IV) infusion over 30 to 60 minutes	Drug	Part 1: BGB-DXP604, Part 2 : BGB-DXP604 + BGB-DXP593
BGB-DXP593Administered as intravenous (IV) infusion over 30 to 60 minutes	Drug	Part 2 : BGB-DXP604 + BGB-DXP593
PlaceboPlacebo to match BGB-DXP593	Drug	Part 2 : BGB-DXP604 + BGB-DXP593
PlaceboPlacebo to match BGB-DXP604	Drug	Part 1: BGB-DXP604, Part 2 : BGB-DXP604 + BGB-DXP593

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time frame: From the day of study drug administration until 30 days after the dose (approximately day 113 )
A TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline on or after the administration of study drug and up to 30 days after the dose of study drug. An SAE is any untoward medical occurrence that, at any dose results in death, or is life threatening, or requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect, or is considered a significant medical AE by the investigator based on medical judgment.

18 secondary outcomes

Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
Time frame: From the day of study drug administration until 30 days after the dose (approximately day 113)
Maximum Observed Serum Concentration (Cmax) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/End of Study (EOS)
Maximum Observed Serum Concentration (Cmax) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Half-life Time (t1/2) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Half-life Time (t1/2) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Clearance (CL) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Clearance (CL) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Volume of Distribution (Vz) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Volume of Distribution (Vz) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
Time frame: Pre-dose and Days 15,29,57,85 and 113/EOS visit

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	6
BGB-DXP604 10 mg/kg	7	6
BGB-DXP604 30 mg/kg	6	6
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg	6	5

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)

Time frame: From the day of study drug administration until 30 days after the dose (approximately day 113 ). Count of participants. Unit: Participants

Measure	Placebo n = 6	BGB-DXP604 10 mg/kg n = 6	BGB-DXP604 30 mg/kg n = 6	BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg n = 6
Participants with at least 1 TEAE	5	3	5	6
Grade 3	0	0	0	0
Grade 4 or Higher	0	0	0	0
SAE	0	0	0	0

Population analysed: Safety Analysis Set

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the day of study drug administration until 30 days after the dose (approximately Day 113). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
BGB-DXP604 10 mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BGB-DXP604 30 mg/kg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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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.

Study Director study director

BeiGene

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 BGB-DXP604 and BGB-DXP593 in people with Healthy, run by BeiGene at 1 site in Australia.

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 4 inclusion and 6 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 26 Oct 2024. 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 Australia. 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?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) (time frame: From the day of study drug administration until 30 days after the dose (approximately day 113 )). 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 NCT04669262.

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 26 Oct 2024.