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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Covid19

Treatments: Drug: BGB DXP593; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04532294

BGB-DXP593-101

Details and patient eligibility

About

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

Enrollment: 18 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/m2 (inclusive) Note: BMI = weight [kg] / (height [m])
3. Negative serum IgG to the SARS-CoV-2
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 taking the study drug; or interfering with the interpretation of data
2. Any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study
3. Have a medical history of SARS infection
4. Any acute fever disease or infections
5. 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

18 participants in 3 patient groups

BGB-DXP593: Dose Level A

Experimental group

Description:

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

Treatment:

Drug: BGB DXP593

BGB-DXP593: Dose Level B

Experimental group

Description:

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

Treatment:

Drug: BGB DXP593

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo