Status:
COMPLETED
BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants
Lead Sponsor:
BeiGene
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04669262
Start Date
December 9 2020
End Date
May 21 2021
Last Update
October 26 2024
Active Locations (1)
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1
Q PHARM
Herston, Queensland, Australia, 4006