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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375

NCT05026008 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-11-29

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers

Conditions

  • Healthy Volunteers

Interventions

DRUG

SR1375

The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water

DRUG

Matching placebo

The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water

Sponsors & Collaborators

  • Shanghai SIMR Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Andrew Redfern · Linear Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-11-30
Completion
2023-03-30

Countries

  • Australia

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 NCT05026008 on ClinicalTrials.gov