None listed
Conditions
Brief summary
Protagonist Therapeutics, Inc. is developing PN-10943A as a potential oral therapy for patients with ulcerative colitis (UC). This study will be conducted in upto 80 normal healthy male subjects who meet all of the inclusion criteria and none of the exclusion criteria. The study is to assess the safety and tolerability of PN-10943A to normal healthy volunteers. This includes vital signs, safety labs, ECGs, and physical examinations The drug will be given in single ascending then multiple ascending doses. The study will also evaluate the PK and PD of the drug after dose administration. Participants will be entered into standard study cohorts.
Interventions
Intervention: PN-10943A
Route of Administration: Oral liquid formulation
Part 1: Single Ascending Dose
Four cohorts will receive a single dose of PN-10943A 100mg, 300mg, 1000mg, 1400mg or placebo. Cohorts will run sequentially. Subjects will be dosed under fasting condition.
The same participants in Cohort 2 (300 mg PN-10943A or placebo) will return to the clinic after a period of at least 7 days to receive a second dose of PN-10943A immediately after ingestion of a standard high fat meal. The
Intervention: PN-10943A Route of Administration: Oral liquid formulation Part 1: Single Ascending Dose Four cohorts will receive a single dose of PN-10943A 100mg, 300mg, 1000mg, 1400mg or placebo. Cohorts will run sequentially. Subjects will be dosed under fasting condition. The same participants in Cohort 2 (300 mg PN-10943A or placebo) will return to the clinic after a period of at least 7 days to receive a second dose of PN-10943A immediately after ingestion of a standard high fat meal. The study schedule for the fed participants will be the same as the fasted participants. Part 2: Multiple Ascending Dose Five cohorts will be enrolled sequentially. Cohort 5: 100 mg PN-10943A or placebo once daily for 14 days; Cohort 6: 300 mg PN-10943A or placebo once daily for 14 days; Cohort 6a: 300 mg PN-10943A once daily on 3 days (Days 1, 8 and 14); Cohort 7: 300 mg PN-10943A or placebo once daily for 14 days with meal interval of 60 minutes; and Cohort 8: 1000 mg PN-10943A or placebo once daily for 14 days. Part 3: Cross over Participants in Cohort 9 will receive PN-10943A (900 mg PN-10943A once daily for 5 days and 450 mg PN-10943A twice daily for 5 days) in a randomised crossover design. All participants in Cohort 9 will receive PN-10943A, no placebo. Each cohort will enrol new subjects. All dosing will be observed by clinic staff to ensure compliance. A record will be maintained by the investigational site which will account for all dispensing and return of any used and unused investigational products. At the end of the study the investigational products will be reconciled.
Sponsors
Protagonist Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Normal healthy volunteers 18-55 years Good general health, BMI 18-30kg/m2 Non-smokers Lab values within normal range. Willing to consume standard meal provided. Ability and willingness to attend visits to the site and provide written informed consent prior to entry into the study.
Exclusion criteria
History of significant abnormalities or diseases Clinical significant lab or ECG abnormalities Mentally or legally incapacitated History of substance abuse, severe allergic or anaphylactic reactions. Regular Alcohol consumption (>21units per week). Inability to comply with the requirements of the study protocol
Outcome results
None listed