ACTRN12618001851257CompletedPhase 1
A randomized, double-blind, placebo-controlled study to assess the safety and tolerability of PN-1094A after single and multiple ascending doses of PN-10943A in normal healthy volunteers
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Protagonist Pty Ltd.
- Enrollment
- 97
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- Male
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
Investigators
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