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A Phase 1 Study to Evaluate the Safety, Tolerability, PK/PD of SRSD107 in Healthy Participants

NCT06116617 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-18

No results posted yet for this study

Summary

The primary aim of this study is to evaluate safety and tolerability data when SRSD107 is administered as single SC injections to healthy participants. This information, along with PK/PD data, will help establish the appropriate doses and dosing regimen for future studies in patients.

Conditions

Interventions

DRUG

SRSD107

SRSD107 is a synthetic, chemically modified double-stranded, small interfering ribonucleic acid (siRNA).

DRUG

Placebo

Sodium chloride

Sponsors & Collaborators

  • Sirius Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qiuyue Qu · Sirius Therapeutics Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2024-12-09
Completion
2025-04-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT06116617 on ClinicalTrials.gov