Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants

NCT04532294 | Completed Phase 1 Results DMC

• 1 other identifier: BGB-DXP593-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and 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

  From the day of study drug administration until 30 days after dose (up to approximately 160 days)

Secondary Outcomes (11)

• Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms

  Up to approximately 160 days

• Number of Participants With Clinically Relevant Changes in Laboratory Parameters

  Up to approximately 160 days

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

  Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)

• Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593

  Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)

• AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593

  Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)

Study Arms (3)

BGB-DXP593: Dose Level A

EXPERIMENTAL

Participants will receive BGB-DXP593 10 mg/kg on Day 1

Drug: BGB DXP593

BGB-DXP593: Dose Level B

EXPERIMENTAL

Participants will receive BGB-DXP593 30 mg/kg on Day 1

Drug: BGB DXP593

Placebo

EXPERIMENTAL

Placebo to match (PTM) BGB-DXP593 on Day 1

Drug: Placebo

Interventions

BGB DXP593 DRUG

Administered intravenously (IV) as specified in the treatment arm

BGB-DXP593: Dose Level A; BGB-DXP593: Dose Level B

Placebo DRUG

Placebo to match BGB-DXP593

Placebo

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/m2 (inclusive) Note: BMI = weight \[kg\] / (height \[m\])
• Negative serum IgG to the SARS-CoV-2
• 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 taking the study drug; or interfering with the interpretation of data
• Any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study
• Have a medical history of SARS infection
• Any acute fever disease or infections
• 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: diabetes mellitus type I, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Q PHARM

Herston, Queensland, 4006, Australia

Location

Related Publications (1)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: August 31, 2020
• Study Start: September 8, 2020
• Primary Completion: February 13, 2021
• Study Completion: February 13, 2021
• Last Updated: October 26, 2024
• Results First Posted: January 27, 2022

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)