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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2021-05-21

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: BGB-DXP604

Part 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo

Group Type EXPERIMENTAL

BGB-DXP604

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo to match BGB-DXP604

Part 2 : BGB-DXP604 + BGB-DXP593

Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo

Group Type EXPERIMENTAL

BGB-DXP604

Intervention Type DRUG

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

BGB-DXP593

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo to match BGB-DXP593

Placebo

Intervention Type DRUG

Placebo to match BGB-DXP604

Interventions

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BGB-DXP604

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

Intervention Type DRUG

BGB-DXP593

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

Intervention Type DRUG

Placebo

Placebo to match BGB-DXP593

Intervention Type DRUG

Placebo

Placebo to match BGB-DXP604

Intervention Type DRUG

Eligibility Criteria

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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/m\^2 (inclusive)
3. Negative SARS-CoV-2 serology test
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)

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 receiving the study drug; or interfering with the interpretation of data
2. 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
3. Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study
4. 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
5. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes