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Completed

NCT Number: NCT04669262

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Q PHARM

Herston, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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.

Treatment and study plan

BGB-DXP604

Drug

Administered as intravenous (IV) infusion over 30 to 60 minutes

BGB-DXP593

Drug

Administered as intravenous (IV) infusion over 30 to 60 minutes

Placebo

Drug

Placebo to match BGB-DXP593

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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