None listed
Conditions
Interventions
Drug : - Intervention label: BIVV020
- Dose formulation: BIVV020 supplied in single use vials containing 750 mg (150 mg/mL
extractable volume of 5 mL)
- Unit dose strength(s): 750 mg/5 mL
- Dosage level(s): One single SC dose of 600 mg and one single IV dose of 50 mg/kg will be given on Day 1 in each group, respectively
-
Sponsors
Sanofi-Aventis Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I 01. East Asian (ethnic Chinese, Japanese or Korean) adult participants, between 20 and 45 years of age, inclusive, at the time of signing the informed consent. The Asian origin classification as Chinese, Japanese or Korean is defined according to the following criteria: • Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China. • Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese. • Korean; born in Korea or ethnic Korean born outside of Korea, and a descendent of 4 ethnic Korean grandparents who were all born in Korea. I 02. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. I 03. Vital signs in supine position after 10 minutes resting within the following ranges: • 95 mmHg < systolic blood pressure (SBP) <140 mmHg. • 45 mmHg < diastolic blood pressure (DBP) <90 mmHg. • 45 bpm < HR <100 bpm. I 04. Standard 12-lead ECG parameters after 10 minutes resting in supine position in the following ranges; 120 ms <PR <220 ms, QRS <120 ms, QTc =450 ms (Fridericia algorithm recommended), 45 bpm <HR <100 bpm and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant. I 05. Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase [AST], ALT), should not exceed the upper laboratory norm. Total bilirubin out of normal range can be acceptable if total bilirubin does not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the participant has documented Gilbert syndrome, for which total bilirubin =3 the upper limit is acceptable). I 06. Body weight within the range from 50 to 100 kg and body mass index (BMI) within the range from 18 to 30 kg/m2, inclusive. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A) Male participants Male participants are eligible to participate if they agree to the following during the intervention period and for at least 52 weeks after the administration of study intervention: • Refrain from donating sperm. PLUS, either: • Be abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR • Must agree to use contraception/barrier as detailed below: - A male condom and an additional highly effective contraceptive method as described in Appendix 4 Contraceptive and barrier guidance (Section 10.4) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. B) Female participants • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Contraceptive and barrier guidance (Section 10.4). OR - Is a WOCBP and agrees to use a double contraceptive method including one that is highly effective (with a failure rate of <1% per year), preferably
Exclusion criteria
Exclusion criteria: E 01. Any history or presence of clinically relevant immunologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. E 02. Serious infections requiring hospitalization within 30 days prior to screening or any active infection requiring treatment during screening. E 03. Current or past diagnosis of SLE or other autoimmune disorders. E 04. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). E 05. Blood donation, any volume, within 2 months before inclusion. E 06. Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP =30 mmHg within 3 minutes when changing from supine to standing position. E 07. Presence or history of drug hypersensitivity or allergic disease diagnosed and treated by a physician. Participants with a history of mild seasonal allergies may be included at the Investigator’s discretion. E 08. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). E 09. Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). E 10. Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). E 11. Any medication, with the exception of hormonal contraception, within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, whichever is longer, any vaccination (except vaccination specified per protocol Section 6.8) within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. E 12. At the time of screening, any participant enrolled in or having participated, in this or any other clinical study, receiving an IMP within 6 months before the first study drug administration. E 13. Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus antibody (anti-HIV Ab), and rapid plasma reagin (RPR) for syphilis. E 14. Positive result on urine drug screen (amphetamines, methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates). E 15. Positive alcohol test. E 16. Positive COVID-19 polymerase chain reaction (PCR) test at screening. E 17. Females who are pregnant (defined as positive human chorionic gonadotropin-beta [ß HCG] test) or lactating. E 18. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. E 19. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. E 20. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6). E 21. Sensitivity or history of hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters: Cmax and AUC0-106d | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: at least tmax, AUClast, AUC, t1/2z, tlast, CL or CL/F, Vz or Vz/F;Assessment of adverse events (AEs)/treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, electrocardiograms (ECGs) and local tolerability at injection site;Complement classical pathway (CP) activity, CH50;Anti-BIVV020 antibodies | — |
Countries
Korea, Republic of
Contacts
Public ContactJooYoung
Seoul National University Hospital
Outcome results
None listed