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NCT02134964

A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects

Completed Phase 1 Last updated 5 March 2015
What this trial tests

Phase 1 trial testing OLT1177 Capsules in Healthy Volunteers in 35 participants. Completed in 1 December 2014.

Timeline
1 June 2014
Primary endpoint
1 December 2014
1 December 2014

Quick facts

Lead sponsorOlatec Therapeutics LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingquadruple
Primary purposebasic science
Enrollment35
Start date1 June 2014
Primary completion1 December 2014
Estimated completion1 December 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Olatec Therapeutics LLC — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The role of inflammasomes in human diseases and their potential as therapeutic targets.
    Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
  2. Targeting pyroptosis in inflammatory bowel disease: A potentially effective therapeutic approach.
    Dong WW, Liu T, He LX, He WT. · · 2025 · cited 1× · PMID 41358180 · DOI 10.3748/wjg.v31.i43.111358
  3. The NLRP3 Inflammasome: Mechanisms of Activation, Regulation, and Therapeutic Opportunities.
    Zou C, Jiang S, Li H, Zhao K, et al · · 2026 · PMID 41799937 · DOI 10.1002/mco2.70660

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Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other Olatec Therapeutics LLC trials

Trials by the same sponsor.

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Data sources for this page

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