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TUC3PII-01_TU2670 Phase IIa Clinical Study

NCT05138562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-08-13

No results posted yet for this study

Summary

This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.

Conditions

  • Endometriosis

Interventions

DRUG

Placebo Comparator: Placebo

4 x placebo capsules, QD

DRUG

Active Comparator: TU2670 320mg

320mg (80mg x 4), QD

DRUG

Active Comparator: TU2670 240mg

240mg (80mg x 3 + placebo x 1), QD

DRUG

Active Comparator: TU2670 120mg

120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD

Sponsors & Collaborators

  • TiumBio Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2024-01-23
Completion
2024-08-05

Countries

  • Czechia
  • Italy
  • Poland
  • Russia
  • Ukraine

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 NCT05138562 on ClinicalTrials.gov