Trichomylin® Safety, Tolerability, and Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of Trichomylin® in healthy adult participants. Up to 56 participants will be enrolled into 1 of 4 SAD cohorts (8 per cohort) and 3 MAD cohorts (8 per cohort). Participants will undergo a S...
The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of Trichomylin® in healthy adult participants. Up to 56 participants will be enrolled into 1 of 4 SAD cohorts (8 per cohort) and 3 MAD cohorts (8 per cohort). Participants will undergo a Screening period between 21 days and 28 days prior to randomization/dose administration (for SAD and MAD respectively), admission to the clinical research unit (CRU), pre-dose assessment, post-dose assessment, and a final end of study (EOS)/follow-up or early termination (ET) visit (if applicable).
Tracking Information
- NCT #
- NCT04867057
- Collaborators
- Novotech (Australia) Pty Limited
- ZYUS Life Sciences Australia Pty Ltd
- Investigators
- Principal Investigator: Paul Wabnitz, Dr CMAX clinical research
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