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Phase 1 Completed N=25 Randomized Double-blind Basic Science

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

Healthy
Source: ClinicalTrials.gov NCT04669262 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) — 5; 3; 5; 6 Participants

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
5; 3; 5; 6; 0; 0
SECONDARY
Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
0; 0; 0; 0; 0; 0
SECONDARY
Maximum Observed Serum Concentration (Cmax) of BGB-DXP593
413.4
SECONDARY
Maximum Observed Serum Concentration (Cmax) of BGB-DXP604
236.9; 744.4; 376.7
SECONDARY
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
7282.4
SECONDARY
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604
5332.3; 15999.4; 8850.6
SECONDARY
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593
7445.4
SECONDARY
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604
5801.2; 17284.1; 9756.2
SECONDARY
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593
4638.0
SECONDARY
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604
2838.6; 8282.9; 4692.8
SECONDARY
Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593
2.93
SECONDARY
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604
1.183; 1.167; 1.275
SECONDARY
Half-life Time (t1/2) of BGB-DXP593
20.96
SECONDARY
Half-life Time (t1/2) of BGB-DXP604
31.46; 30.56; 32.03
SECONDARY
Clearance (CL) of BGB-DXP593
0.15
SECONDARY
Clearance (CL) of BGB-DXP604
0.11; 0.11; 0.11
SECONDARY
Volume of Distribution (Vz) of BGB-DXP593
4.59
SECONDARY
Volume of Distribution (Vz) of BGB-DXP604
5.00; 4.78; 5.55
SECONDARY
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
0; 0; 0; 0; 0; 0

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04669262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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