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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BGB-DXP593; Drug: Placebo; Drug: BGB-DXP604

Study type: Interventional

Funder types: Industry

Identifiers

NCT04669262

BGB-DXP604-101

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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/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)

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 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Part 1: BGB-DXP604

Experimental group

Description:

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

Treatment:

Drug: BGB-DXP604

Drug: Placebo

Drug: Placebo

Part 2 : BGB-DXP604 + BGB-DXP593

Experimental group

Description:

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

Treatment:

Drug: BGB-DXP604

Drug: Placebo

Drug: BGB-DXP593

Drug: Placebo