Health TrialsbyHealthPanel

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

ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOrsoBio, Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive

Body mass index from 19 to 35 kg/m2, inclusive

Estimated glomerular filtration rate ≥ 80 mL/min

Normal liver biochemistry tests

Disqualifiers

Pregnant or lactating subjects

Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol

Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing

Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety

Trial design

Design model

Sequential

Treatments tested in this trial

  • TLC-1180 Oral Solution

    Drug

    Oral solution of TLC-1180

  • TLC-1180 Tablet

    Drug

    Tablet formulation of TLC-1180

  • Placebo Oral Solution

    Other intervention

    Placebo-to-match oral solution TLC-1180

  • Placebo Tablet

    Other intervention

    Placebo-to-match tablet formulation of TLC-1180

Treatment groups

332 Participants
are divided into 2 treatment groups
Group A: Oral SolutionExperimental treatment 2 interventions
Group B: TabletExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of TLC-1180 treatment-emergent adverse events

Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v6.0). The relationship between AEs and the study drug will be indicated as related or not related.

Time frame
Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
2

PK of TLC-1180 AUC

Area under the concentration-time curve

Time frame
Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
3

PK of TLC-1180 Cmax

Maximum plasma concentration

Time frame
Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
4

PK of TLC-1180 tmax

Time to reach Cmax

Time frame
Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OrsoBio, Inc

Lead sponsor

Source ClinicalTrials.gov
Apply now