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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04532294




Registration number
NCT04532294
Ethics application status
Date submitted
27/08/2020
Date registered
31/08/2020
Date last updated
25/11/2020

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
Scientific title
A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Healthy Subjects
Secondary ID [1] 0 0
BGB-DXP593-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code

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

Experimental: BGB-DXP593: Dose Level A - Participants will receive BGB-DXP593 10 mg/kg on Day 1

Experimental: Placebo: Dose Level A - Participants will receive placebo to match (PTM) BGB-DXP593 10 mg/kg on Day 1

Experimental: BGB-DXP593: Dose Level B - Participants will receive BGB-DXP593 30 mg/kg on Day 1

Experimental: Placebo: Dose Level B - Participants will receive placebo to match (PTM) BGB-DXP593 30 mg/kg on Day 1

Experimental: BGB-DXP593: Dose Level C - BGB-DXP593 at a higher dose determined from the two previous dose levels on Day 1

Experimental: Placebo: Dose Level C - Placebo to match (PTM) BGB-DXP593 at a higher dose determined from the two previous dose levels on Day 1


Treatment: Drugs: BGB DXP593
Administered intravenously (IV) as specified in the treatment arm

Treatment: Drugs: Placebo
Placebo to match BGB-DXP593

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 113 days
Primary outcome [2] 0 0
Number of participants experiencing Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 113 days
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of BGB-DXP593
Timepoint [1] 0 0
Up to 113 days
Secondary outcome [2] 0 0
Area under the plasma concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration (AUCt) of BGB-DXP593
Timepoint [2] 0 0
Up to 113 days
Secondary outcome [3] 0 0
AUC from time zero to infinity (AUCinf) of BGB-DXP593
Timepoint [3] 0 0
Up to 113 days
Secondary outcome [4] 0 0
AUC from time zero to Day 29 (AUC0-29) of BGB-DXP593
Timepoint [4] 0 0
Up to Day 29
Secondary outcome [5] 0 0
Time to maximum observed plasma concentration (tmax) of BGB-DXP593
Timepoint [5] 0 0
Up to 113 days
Secondary outcome [6] 0 0
Terminal half life (t1/2) of BGB-DXP593
Timepoint [6] 0 0
Up to 113 days
Secondary outcome [7] 0 0
Clearance (CL) of BGB-DXP593
Timepoint [7] 0 0
Up to 113 days
Secondary outcome [8] 0 0
Volume of distribution (Vz) of BGB-DXP593
Timepoint [8] 0 0
Up to 113 days
Secondary outcome [9] 0 0
Immunogenic response to BGB-DXP593 as assessed by the Detection of antidrug antibodies (ADA)
Timepoint [9] 0 0
Up to 113 days

Eligibility
Key inclusion criteria
Key Inclusion Criteria :

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/m2
(inclusive) Note: BMI = weight [kg] / (height [m])

3. Negative serum IgM and IgG to the SARS-CoV-2

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
Gender
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 taking the study drug; or interfering with the interpretation of
data

2. Any history of a severe allergic reaction prior to enrollment that has a reasonable
risk of recurrence during the study

3. Have a medical history of SARS infection

4. Any acute fever disease or infections

5. 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: diabetes mellitus type I, chronic hepatitis; or clinically significant
forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune
disease, psychiatric disorders, or heart disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Basic Science
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 administering the treatment/s

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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593
administered intravenously as a single dose in healthy participants
Trial website
https://clinicaltrials.gov/show/NCT04532294
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zhen Yao
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
+1 877 828 5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04532294