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Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation

NCT04867057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-06-27

No results posted yet for this study

Summary

This is a first in human, randomized, double-blind, placebo-controlled SAD (with food effect) followed by a MAD study of Trichomylin® conducted in healthy adult participants.

Conditions

Interventions

DRUG

Trichomylin for SAD

Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.

DRUG

Placebo for SAD

Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.

DRUG

Trichomylin for MAD

Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered daily oral doses for a total of 9 days.

DRUG

Placebo for MAD

Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered daily oral doses for a total of 9 days.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • ZYUS Life Sciences Australia Pty Ltd

    collaborator UNKNOWN

  • ZYUS Life Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Wabnitz, Dr · CMAX clinical research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-02-18
Completion
2022-05-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867057 on ClinicalTrials.gov