None listed
Conditions
Brief summary
The study is to assess the safety and tolerability of PTG300 in normal healthy volunteers. This includes vital signs, safety labs and physical examinations Study drug (a single dose of either PTG-300 or placebo, or two doses a week apart) will be given as a subcutaneous injection. The study will also evaluate the PK of the drug after dose administration, and effects of PTG300 on iron levels. Participants will be entered into standard study cohorts of 10, 8 active:2 placebo for Cohorts 1 to 6, and 6 (5 active: 1 placebo) for Cohort 7
Interventions
Cohort 1: PTG300 1mg subcutaneous injection of 0.9mL, once
Cohort 2: PTG300 3mg subcutaneous injection of 0.9mL, once
Cohort 3: PTG300 10mg subcutaneous injection of 0.9mL, once
Cohort 4 PTG300 20mg subcutaneous injection of 0.9mL, once
Cohort 5: PTG300 40mg subcutaneous injection of 0.9mL, once
Cohort 6: PTG300 80mg subcutaneous injection of 0.9mL, once
Cohort 7: 2 x PTG300 40mg subcutaneous injections of 0.9mL, one week apart
Sponsors
Protagonist Therapeutics, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male volunteers aged 18-60. Good general health, Body weight at least 50 kg and Body Mass Index between 18 and 30 kg/m2. No clinically significant laboratory values Non-smokers
Exclusion criteria
Iron supplementation or history of iron deficiency anaemia History of significant abnormalities or diseases Clinical significant laboratory, vital sign or ECG abnormalities Mentally or legally incapacitated History of substance abuse Inability to comply with the requirements of the study protocol
Outcome results
None listed