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Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04532294
Recruitment Status : Completed
First Posted : August 31, 2020
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

Condition or disease Intervention/treatment Phase
Covid19 Drug: BGB DXP593 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : September 8, 2020
Actual Primary Completion Date : January 15, 2021
Actual Study Completion Date : February 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BGB-DXP593: Dose Level A
Participants will receive BGB-DXP593 10 mg/kg on Day 1
Drug: BGB DXP593
Administered intravenously (IV) as specified in the treatment arm

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

Experimental: BGB-DXP593: Dose Level B
Participants will receive BGB-DXP593 30 mg/kg on Day 1
Drug: BGB DXP593
Administered intravenously (IV) as specified in the treatment arm

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

Experimental: BGB-DXP593: Dose Level C
BGB-DXP593 at a higher dose determined from the two previous dose levels on Day 1
Drug: BGB DXP593
Administered intravenously (IV) as specified in the treatment arm

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
Drug: Placebo
Placebo to match BGB-DXP593




Primary Outcome Measures :
  1. Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 113 days ]
  2. Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 113 days ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  2. Area under the plasma concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration (AUCt) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  3. AUC from time zero to infinity (AUCinf) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  4. AUC from time zero to Day 29 (AUC0-29) of BGB-DXP593 [ Time Frame: Up to Day 29 ]
  5. Time to maximum observed plasma concentration (tmax) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  6. Terminal half life (t1/2) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  7. Clearance (CL) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  8. Volume of distribution (Vz) of BGB-DXP593 [ Time Frame: Up to 113 days ]
  9. Immunogenic response to BGB-DXP593 as assessed by the Detection of antidrug antibodies (ADA) [ Time Frame: Up to 113 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532294


Locations
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Australia, Queensland
Q Pharm Pty Limited
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Zhen Yao BeiGene
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04532294    
Other Study ID Numbers: BGB-DXP593-101
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases