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First in Human Study of ORG-129 in Healthy Volunteers

NCT04933565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-01-17

No results posted yet for this study

Summary

The current study is performed to characterize the safety, tolerability and pharmacokinetics of ORG-129 after oral intake in healthy male and female volunteers after single ascending and multiple ascending doses.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ORG-129

ORG-129 oral capsules

DRUG

Placebo

Placebo oral capsules

Sponsors & Collaborators

  • Origo Biopharma

    lead INDUSTRY

Principal Investigators

  • Juan Martinez-Colomer, MD · Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-12-12
Completion
2023-01-09

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT04933565 on ClinicalTrials.gov