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

NCT06657703 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HC022

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Sponsors & Collaborators

  • HC Biopharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2025-08-30
Completion
2026-01-08

Countries

  • China

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 NCT06657703 on ClinicalTrials.gov