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Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects

NCT05948059 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-11-15

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study with the primary objective of evaluating the safety and tolerability of SHR-2106 in healthy subjects after a single intravenous or subcutaneous administration.

Conditions

  • Kidney Transplantation

Interventions

DRUG

SHR-2106 injection or placebo

starting dose from 50 mg

DRUG

SHR-2106 injection or placebo

starting dose from 300 mg

Sponsors & Collaborators

  • Guangdong Hengrui Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2024-06-15
Completion
2024-06-15

Countries

  • China

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 NCT05948059 on ClinicalTrials.gov