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RECRUITING
NCT06657703
PHASE1

Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.

Sponsor: HC Biopharma Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects;To evaluate the immunogenicity of HC022 administered to healthy subjects.

Official title: A Phase Ia Single Center, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Doses of HC022 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2024-11-25

Completion Date

2026-01-08

Last Updated

2025-04-17

Healthy Volunteers

Yes

Interventions

DRUG

HC022

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Locations (3)

Peking Union Medical College Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The Clinical Pharmacology Research Center of PUMCH

Beijing, China