VIS649-102: A study assessing single doses of VIS649, in healthy adults.
VIS649-102: A sequential treatment, phase 1, open-label study to assess the pharmacokinetics, safety and tolerability, and pharmacodynamics of VIS649 solution administered subcutaneously in healthy male and female participants aged 18 to 55 years.
IQVIA RDS Pty Limited
48 participants
Dec 7, 2020
Interventional
Conditions
Summary
This is a Phase 1, Open-label study performed to determine the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of the study drug, VIS649 solution when administered subcutaneously in healthy non-Japanese and Japanese males and females aged between 18 and 55 years. The assessment will be done in up to 3 dose cohorts. The results will facilitate the treatment of immunoglobulin (Ig) A nephropathy. The study comprises of a screening period up to 30 days before dosing, an in-house stay for approximately 3 days (in which dosing will be done on first day and discharge on second day), followed by a post-administration period of 16 weeks with follow-up visits. The total duration of the clinical study per participant will be up to approximately 20 weeks (5 months), including the screening period. A total of 36 participants (12 in each cohort) will be enrolled with 9 Non-Japanese and 3 Japanese in each cohort. A Safety Monitoring Committee will be used for reviewing safety and tolerability data of the study.
Eligibility
Inclusion Criteria7
- Healthy males and females between 18 and 55 years of age (inclusive)
- Body mass index (BMI) 17 - 32 kg/m2, inclusive
- Willing to adhere to study rules and restrictions
- Willing to follow contraception requirements
- Capable of giving informed consent
- Pass all screening assessments (WBC and platelets count; hemoglobin; eGFR; serum creatinine; glucose; serum IgG, IgM and IgA levels;
- Willing and able to comply with study restrictions and to remain at the study site for the in-patient duration of the study and return for all follow-up visits
Exclusion Criteria18
- Female participants who are pregnant or breastfeeding.
- Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder including psychiatric disorders, cirrhosis, or malignancy.
- Participant has a history or presence of proteinuria, chronic kidney disease, disease requiring immunosuppressive therapy or is considered to be immunosuppressed for any reason.
- History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
- Known hypoglobulinemia disorder.
- History of chronic infection or any infection requiring hospitalization or treatment within 30 days.
- Received vaccination in prior 30 days
- Alanine transaminase (ALT) or aspartate transaminase (AST) >1.5 x ULN; total bilirubin .1.5 x ULN.
- Known hepatic or biliary abnormalities
- A QT interval corrected for heart rate using Fridericia's correction (QTcF) .450 msec for males or >470 msec for females.
- Previous receipt of antibody or biologic therapy
- Concomitant use of marketed or investigational systemic immunosuppressive or immunomodulatory medications is prohibited and requires a a washout period prior to screening.
- Is participating in another clinical study of any investigational drug, device or intervention within the last 30 days or 5 half-lives of the intervention, whichever is longer.
- Meets required diagnostic assessments for blood pressure, presence of hepatitis B surface antigen, chronic hepatitis C infection, presence of hepatitis B core antibody, known history of positive human immunodeficiency virus, positive urine drug or alcohol breath screen at screening or Day -1.
- Male who consumes more than 15 standard alcohol drinks per week or female who consumes more than 10 standard alcohol drinks per week.
- Participant who has donated >500 ml of blood within 7 days prior to baseline.
- Is an employee of the clinical research team.
- Participant judged by the primary investigator or the medical monitor to be inappropriate for the study.
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Interventions
Participants will receive a single dose of VIS649 administered via subcutaneous injection by the investigator. Group 1 will receive 200 mg VIS649, Group 2 will receive 400 mg VIS649, Group 3 will receive 400 mg VIS649 and Group 4 will receive 600 mg VIS649.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12620001352998