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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;

• Aged 18 to 55 years old, inclusive, male or female;

• 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must have a body mass index between 19 and 28 kilogram per square meter (kg/m2);

• Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG;

• All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3 months (for male) after their dose of study treatment;

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
The Clinical Pharmacology Research Center of PUMCH
RECRUITING
Beijing
Contact Information
Primary
Langxi Zhang, PhD
langxi.zhang@btyy.com
8602150433368
Backup
The Clinical Pharmacology Research Center of PUMCH
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2026-01-08
Participants
Target number of participants: 38
Treatments
Experimental: HC022 5mg SC
Participants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.
Experimental: HC022 50mg SC
Participants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.
Experimental: HC022 150mg SC
Participants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.
Experimental: HC022 450mg SC
Participants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.
Experimental: HC022 900mg SC
Participants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.
Related Therapeutic Areas
Sponsors
Leads: HC Biopharma Inc.

This content was sourced from clinicaltrials.gov

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