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RECRUITING
NCT07771140
PHASE1

A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Trial With Single and Multiple Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of HECN30227 Injection in Healthy Volunteers and Subjects With Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2025-12-02

Completion Date

2027-04-11

Last Updated

2026-08-18

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HECN30227 injection(SAD)

single subcutaneous administrations

DRUG

Placebo(MAD)

0.9% Sodium Chloride Injection

DRUG

Placebo(SAD)

0.9% Sodium Chloride Injection

DRUG

HECN30227 injection (MAD)

multiple subcutaneous administrations

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, China