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

NCT04669262 | Completed Phase 1 Results DMC

• 1 other identifier: BGB-DXP604-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)

  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.

  From the day of study drug administration until 30 days after the dose (approximately day 113 )

Secondary Outcomes (18)

• Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings

  From the day of study drug administration until 30 days after the dose (approximately day 113)

• Maximum Observed Serum Concentration (Cmax) of BGB-DXP593

  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)

• Maximum Observed Serum Concentration (Cmax) of BGB-DXP604

  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

• Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593

  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

• Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604

  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

Study Arms (2)

Part 1: BGB-DXP604

EXPERIMENTAL

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

Drug: BGB-DXP604; Drug: Placebo

Part 2 : BGB-DXP604 + BGB-DXP593

EXPERIMENTAL

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

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

Interventions

BGB-DXP604 DRUG

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

Part 1: BGB-DXP604; Part 2 : BGB-DXP604 + BGB-DXP593

BGB-DXP593 DRUG

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

Part 2 : BGB-DXP604 + BGB-DXP593

Placebo DRUG

Placebo to match BGB-DXP593

Part 2 : BGB-DXP604 + BGB-DXP593

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Q PHARM

Herston, Queensland, 4006, Australia

Location

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 16, 2020
• Study Start: December 9, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: October 26, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)