None listed
Conditions
Brief summary
This study will be a single-centre, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK of GMA301 (thereafter referred to as getagozumab), in healthy subjects. Four sequential dosing cohorts, each with 6 subjects receiving getagozumab and 2 subjects receiving placebo (total of 32 subjects), will be given increasing single doses of getagozumab. sentinel dosing is proposed for each group. Two sentinel subjects (1:1 active to placebo) will be dosed first and the remaining 6 subjects in the cohort will be dosed 7 days later, followed by at least 12 days prior to the next cohort dosing. After Screening (Screening Period of 28 days), eligible subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized into the study. A computer-generated randomization schedule will be used. The treatment period will last up to 8 weeks, followed by a 2-week follow-up period.
Interventions
This study will be a single-centre, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK of GMA301 (thereafter referred to as getagozumab), in healthy subjects. Four sequential dosing cohorts, each with 6 subjects receiving getagozumab and 2 subjects receiving placebo (total of 32 subjects), will be given increasing intravenous infusion,single doses of getagozumab. The doses administered will be 75, 200, 500, and 1000 mg, or matching placebo at Day 1
This study will be a single-centre, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK of GMA301 (thereafter referred to as getagozumab), in healthy subjects. Four sequential dosing cohorts, each with 6 subjects receiving getagozumab and 2 subjects receiving placebo (total of 32 subjects), will be given increasing intravenous infusion,single doses of getagozumab. The doses administered will be 75, 200, 500, and 1000 mg, or matching placebo at Day 1 and monitor the adherence to the intervention by direct observation. As a conservative measure for the safety of healthy human subjects in this Phase 1 study of getagozumab, sentinel dosing is proposed for each group. Two sentinel subjects (1:1 active to placebo) will be dosed first and the remaining 6 subjects in the cohort will be dosed 7 days later, followed by at least 12 days prior to the next cohort dosing. Before proceeding to the next cohort, the Safety Review Committee (SRC; including an independent SRC member or SRC members) will have to review all the clinical data of the just finished cohort and approve the dosing of the next cohort. After Screening (Screening Period of 28 days), eligible subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized into the study. A computer generated randomization schedule will be used. The treatment period will last up to 8 weeks, followed by a 2 week follow-up period. Blood sampling for PK will be performed at: predose, 4 hours (h), 8h, 24h, 72h, 168h (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 (Week 8), and Week 10. At each time point, 3 mL of whole blood will be collected for PK analyses.
Sponsors
Gmax Biopharm Australia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy male and female subjects 18 to 60 years old, inclusive, at the time of Screening, as confirmed by medical history, physical examination, and routine laboratory tests. • Routine clinical laboratory tests within normal range or minor deviations not deemed clinically important by the investigator. • Body mass index (BMI) of 18.5 kg/m2 to 30.0 kg/m2, inclusive, at Screening. • Blood pressure (BP) and pulse rate at Screening within normal range (ie, systolic 90-140 mmHg, diastolic 60-90 mmHg, and pulse rate 40-100 bpm). Up to 2 additional measurements may be taken after an appropriate resting interval (at least 10 minutes) at Screening to confirm eligibility. • Female subjects (or female partners of male subjects) of childbearing potential must have a negative serum pregnancy test result within 48 hours prior to receiving study drug (female subjects only) and must agree to avoid pregnancy by using an accepted form of highly effective contraception during the study and for 6 months after study drug administration. • Negative screen for drugs of abuse and alcohol at Screening. • Male subjects must agree not to donate sperm during the study and for 6 months after study drug administration. Male subjects must agree to avoid causing pregnancy by using a reliable method of birth control during the study and for 6 months after study drug administration. • Give written informed consent to participate in the study prior to any screening procedures.
Exclusion criteria
• Presence or history of any clinically significant chronic condition of the neurological, respiratory, cardiovascular, gastrointestinal, urogenital, reproductive, musculoskeletal, endocrine system or cancer . • Clinically significant (as judged by the investigator) presence of acute illness (eg, gastrointestinal illness, infection such as influenza, upper respiratory tract infection) upon admission to the study site • Alanine aminotransferase and/or aspartate aminotransferase above the upper limit of normal. • Hemoglobin below lower limit of normal. • Positive serology test results for hepatitis B, hepatitis C, and/or human immunodeficiency virus at Screening. • Clinically significant abnormality in the 12-lead electrocardiogram (ECG) as judged by the investigator. • Currently enrolled in a clinical trial or have been enrolled in a clinical trial involving an investigational product or medical device that acts on the cardiovascular system, respiratory system, or endocrine system within at least 1 month with 5 half-lives of the tested agent (whichever was shorter) prior to Screening. • Women who are pregnant, intend to become pregnant, or are lactating. • History of type 1 hypersensitivity or severe cutaneous adverse reaction to any medication, or history of significant atopy. • Use of prescription medications or over-the-counter medications within 7 days prior to study drug administration, with the exception of simple analgesics such as paracetamol and routine vitamins. • Donated more than 500 mL of blood within 4 weeks prior to study enrollment, or donated plasma or participated in a plasmapheresis program within 7 days of study drug administration. • Average weekly alcohol intake that exceeds 14 units per week (males ) or 7 units (females) per week, or are unwilling to stop alcohol consumption for 24 hours prior to study drug dosing until the completion of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine;1.5 oz or 45 mL of distilled spirits). • Current smoker, or a history of regular (more than weekly) use of tobacco or nicotine-containing products within 2 months prior to Screening. • In the opinion of the investigator or sponsor, deemed unsuitable for inclusion in the study.
Outcome results
None listed