A Phase 1, Randomised, Double-Blind, placebo controlled, single and multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of KZR-616 in healthy female subjects.
- Conditions
- Chronic inflammatory conditions for example rheumatoid arthritisAutoimmune disorders for example systemic lupus erythematosusInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12618002060224
- Lead Sponsor
- Clinical Netwprk Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 72
1. Female, normal healthy volunteer (NHV), age at screening 18 to 55 years, inclusive.
2. In good general health, with no significant medical history and with no clinically significant
abnormalities on physical examination at Screening or before administration of the initial
dose of study drug.
3. Body mass index (BMI) between 18 and 32 kg/m2 inclusive.
4. Suitable injection sites on abdomen without confounding scars or lesions (for Part 1 subjects)
or accessible venous access (for Part 2 subjects).
5. Agrees to abstain from alcohol intake 48 hours before administration of study agent, during
the inpatient period of the study and during the 24 hours prior to a study visit.
6. Have the ability and willingness to attend the necessary visits to the study centre.
7. Have provided written informed consent prior to entry into the study.
8. If of childbearing potential, subject has a negative serum pregnancy test at Screening and a
negative urine pregnancy test at Day -1 and agrees to employ adequate birth control measures
for the duration of the study from Screening and for 90 days following the last dose of
KZR-616 Lyophile.
a. For the purposes of this trial, women of childbearing potential (WOCBP) are defined as
all female subjects after puberty unless they are postmenopausal (defined by amenorrhea
for at least 1 year with confirmatory follicle stimulating hormone [FSH] level in the
postmenopausal range if subject is not on supplementary hormonal therapy; or if onhormonal replacement therapy, age over 55 and 2 years of amenorrhea) or are surgically
sterile (i.e. tubal ligation, hysterectomy, bilateral salpingoophorectomy) with procedure
performed at least 12 months prior to Screening with no evidence of pregnancy since the
procedure.
b. Adequate birth control is defined as the use of double-barrier contraception which is
defined as use of a condom by the male partner and one other form of the following:
- i. Hormonal contraceptives: oral, implant, ring, patch, or depot/injectable method
which has been used for at least 4 weeks before Screening in a stable manner
- ii. Intrauterine device (IUD)
- iii. Male partner with vasectomy with documented aspermia post procedure or
documented congenital sterility
c. Rhythm, withdrawal and periodic abstinence (e.g., calendar, ovulation) methods will not
be considered adequate birth control for this study. Subject abstinence for the duration of
the study and 90 days after the last dose of KZR-616 Lyophile is acceptable. Subjects
with same sex partners are not required to be using contraception.
Subjects must NOT meet any of the following exclusion criteria to be enrolled:
1. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg),
hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV) at Screening.
2. Positive QuantiFERON-TB (QFT) assay (or indeterminate result from repeat assessment) at
Screening.
3. Active infection (diagnosed or suspected) or a history of recurrent infections (defined as 3 or
more infections requiring antimicrobial intervention in the last 12 months prior to Day 1).
4. Serious local infection or systemic infection within 3 months of Day 1 requiring injectable
antimicrobial treatment.
5. Any clinically significant acute illness within 30 days prior to Day 1.
6. Any underlying physical or psychological medical condition that, in the opinion of the PI,
would make it unlikely that the subject will complete the study.
7. Surgery within the past 3 months prior to the first study drug administration determined by
the PI to be clinically relevant.
8. Evidence of any ongoing chronic medical condition (e.g., hypertension, asthma or diabetes).
9. Use of any prescription or over-the counter (OTC) medication (with the exception of
multivitamin, paracetamol and hormonal contraceptives) within 7 days of randomization
unless PI and Sponsor agree that the specific use of a prior medication is unlikely to impact
the state objectives of this trial.
10. Receipt of any live vaccine within 1 month of randomization.
11. Any clinically significant laboratory abnormality.
12. Absolute neutrophil count <1500/µL or haemoglobin <11 g/dL.
13. Any other clinical laboratory values >1.2 x upper limit of normal (ULN) as specified by the
testing laboratory, unless deemed not clinically significant (NCS) by the PI.
14. History or presence of alcoholism or drug abuse within the 2 years prior to the first study
drug administration.
15. Positive urine drug screen or alcohol breath test at Screening or Day -1.
16. Donated or received blood products or experienced significant blood loss within 60 days prior
to the first study drug administration.
17. Donated or received plasma within 7 days prior to the first study drug administration.
18. Received investigational product (IP) in another trial within 30 days prior to the first study
drug administration.
19. Previously received KZR-616.
20. Pregnant or lactating.
21. Failure to satisfy the PI of fitness to participate in the study for any other reason.
22. Known or suspected hypersensitivity to a, a-trehalose dihydrate (trehalose).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of KZR-616 as assessed by the incidence, nature and severity of AEs and serious adverse events (SAEs).<br>Known possible adverse events include: <br>- Injection site reactions. <br>-Nausea<br>-myalgia (muscle aches)<br>-headache<br>-rash<br>-dizziness<br>-fatigue<br>-upper respiratory tract infection<br>-influenza like (flu like) illness<br>These will be assessed by clinical examination.[After any subject has been enrolled to 30 days following final dose, whether or not they are related to the study ]
- Secondary Outcome Measures
Name Time Method