Phase 1
Completed N=18
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
Source: ClinicalTrials.gov NCT04532294 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 4; 4; 4; 0 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
4; 4; 4; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Laboratory Parameters |
0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 |
255.3; 667.0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593 |
4168.8; 12422.6 | — |
| SECONDARY AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593 |
3964.6; 11434.2 | — |
| SECONDARY AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593 |
2368.4; 6683.9 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593 |
1.47; 3.67 | — |
| SECONDARY Terminal Half Life (t1/2) of BGB-DXP593 |
26.60; 25.77 | — |
| SECONDARY Clearance (CL) of BGB-DXP593 |
0.18; 0.19 | — |
| SECONDARY Volume of Distribution (Vz) of BGB-DXP593 |
6.54; 6.30 | — |
| SECONDARY Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA) |
1; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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)
Key Exclusion Criteria
- 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04532294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.