NCT04867057 - Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation | Biotech Hunter

Enrollment

41

Participants

Timeline

Start Date

April 19, 2021

Primary Completion Date

February 18, 2022

Study Completion Date

May 30, 2022

Conditions

HealthyOsteoarthritis

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.

Trial Locations (1)

5000

CMAX Clinical Research, Adelaide