NCT06224400 - A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects | Biotech Hunter

Enrollment

72

Participants

Timeline

Start Date

March 5, 2024

Primary Completion Date

September 9, 2024

Study Completion Date

April 15, 2025

Conditions

Healthy

Interventions

DRUG

ENC1018 for SAD

SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort A1-A6) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally as a single dose.

DRUG

Placebo for SAD

SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort A1-A6) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally as a single dose.

DRUG

ENC1018 for MAD

MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort B1-B3) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally for a total of 14 days.

DRUG

Placebo for MAD

MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort B1-B3) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally for a total of 14 days.

Trial Locations (1)

3004

Nucleus Network Pty Ltd., Melbourne