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The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers

NCT05012761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-29

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

SR419 capsules

Ascending single and multiple doses of SR419 orally

DRUG

Placebo

Ascending single and multiple doses of placebo orally

Sponsors & Collaborators

  • Shanghai SIMR Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen Yu · Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2021-12-27
Completion
2022-05-27

Countries

  • China

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 NCT05012761 on ClinicalTrials.gov