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A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects

NCT07300189 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-04-14

No results posted yet for this study

Summary

This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.

Conditions

  • Healthy Participants

Interventions

DRUG

TLC-1180 Oral Solution

Oral solution of TLC-1180

DRUG

TLC-1180 Tablet

Tablet formulation of TLC-1180

OTHER

Placebo Oral Solution

Placebo-to-match oral solution TLC-1180

OTHER

Placebo Tablet

Placebo-to-match tablet formulation of TLC-1180

Sponsors & Collaborators

  • OrsoBio, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-04-01
Completion
2027-06-01

Countries

  • New Zealand

Study Locations

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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 NCT07300189 on ClinicalTrials.gov