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A Phase I Study of RC1416 Injection

NCT06067490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-02

No results posted yet for this study

Summary

This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

RC1416(SAD)

RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection.

DRUG

Placebo(SAD)

Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.

Sponsors & Collaborators

  • Nanjing RegeneCore Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li J Tong, Doctor · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2024-05-14
Completion
2024-05-14
FDA Drug
Yes

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 NCT06067490 on ClinicalTrials.gov