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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04669262




Registration number
NCT04669262
Ethics application status
Date submitted
4/12/2020
Date registered
16/12/2020

Titles & IDs
Public title
BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants
Scientific 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
Secondary ID [1] 0 0
BGB-DXP604-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-DXP604
Treatment: Drugs - BGB-DXP593
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Part 1: BGB-DXP604 - Part 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo

Experimental: Part 2 : BGB-DXP604 + BGB-DXP593 - Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo


Treatment: Drugs: BGB-DXP604
Administered as intravenous (IV) infusion over 30 to 60 minutes

Treatment: Drugs: BGB-DXP593
Administered as intravenous (IV) infusion over 30 to 60 minutes

Treatment: Drugs: Placebo
Placebo to match BGB-DXP593

Treatment: Drugs: Placebo
Placebo to match BGB-DXP604
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From the day of study drug administration until 30 days after the dose (approximately day 113 )
Secondary outcome [1] 0 0
Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
Timepoint [1] 0 0
From the day of study drug administration until 30 days after the dose (approximately day 113)
Secondary outcome [2] 0 0
Maximum Observed Serum Concentration (Cmax) of BGB-DXP593
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Maximum Observed Serum Concentration (Cmax) of BGB-DXP604
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593
Timepoint [8] 0 0
Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Secondary outcome [9] 0 0
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604
Timepoint [9] 0 0
Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Secondary outcome [10] 0 0
Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Half-life Time (t1/2) of BGB-DXP593
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Half-life Time (t1/2) of BGB-DXP604
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
Clearance (CL) of BGB-DXP593
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
Clearance (CL) of BGB-DXP604
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Volume of Distribution (Vz) of BGB-DXP593
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Volume of Distribution (Vz) of BGB-DXP604
Timepoint [17] 0 0
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
Secondary outcome [18] 0 0
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
Timepoint [18] 0 0
Pre-dose and Days 15,29,57,85 and 113/EOS visit

Eligibility
Key inclusion criteria
Key

1. 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
2. Body weight = 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)
3. Negative SARS-CoV-2 serology test
4. 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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
2. 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
3. Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study
4. 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
5. 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/05/2021
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q Pharm Pty Limited - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04669262