A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KZR-616 in Healthy Subjects
- Conditions
- Autoimmune diseasesInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12616001040459
- Lead Sponsor
- Clinical Network Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 128
1. Normal healthy volunteers, age at screening 18 to 65 years, inclusive.
2. Subjects must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
3. Subjects must weigh more than or equal to 50 kg and have a Body Mass Index between 20 and 29 kg/m2 Inclusive.
4. Subjects must have clinical laboratory values less than 1.5 x upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant by the Investigator.
5. Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study.
6. Negative urine drug screen /alcohol breath test at screening and Day -1.
7. Subjects must have the ability and willingness to attend the necessary visits to the study centre.
8. Written informed consent signed prior to entry into the study.
9. Subjects using highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following the last dose of KZR-616
Double barrier contraception is defined as a condom AND one other form of the following:
-Birth control pills (The Pill)
-Depot or injectable birth control
-IUD (Intrauterine Device)
-Birth Control Patch (e.g., Othro Evra)
-NuvaRing, Registered Trademark
-Documented evidence of surgical sterilization at least 6 months prior to screening visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men.
Males must not donate sperm for at least 90 days post-dose of the last study treatment. Male partners of female subjects and female partners of male subjects must also use contraception, if they are of childbearing potential.
Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level greater than 40 mIU/mL.
Rhythm methods will not be considered as highly effective methods of birth control. Subject abstinence for the duration of the study and 90 days after the dose of KZR-616 is acceptable.
1. Positive testing for human immunodeficiency virus (HIV),hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
2. Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the subject will complete the study
3. Have evidence of any chronic medical condition (e.g., hypertension, elevated cholesterol/triglycerides, asthma, or diabetes).
4. Use of any prescription or over-the counter medication (with the exception of paracetamol and oral contraceptives) within 7 days of randomization.
5. Any clinically significant laboratory abnormality.
6. Absolute neutrophil count less than 1500/microliter.
7. Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 x ULN unless not clinically significant (NCS) by investigator discretion.
8. History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
9. Blood donation or significant blood loss within 60 days prior to the first study drug administration.
10. Plasma donation within 7 days prior to the first study drug administration.
11. Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration.
12. Females who are pregnant or lactating.
13. Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
14. Failure to satisfy the PI of fitness to participate for any other reason.
15. Active infection (diagnosed or suspected) or history of recurrent infections.
16. Serious local infection or systemic infection within 3 months requiring antibiotic treatment.
17. Any acute illness within 30 days prior to Day 1.
18. Known or suspected hypersensitivity to polysorbate 80 (PS-80, also known as (aka) Tween 80)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method