Actively Recruiting
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Led by HC Biopharma Inc. · Updated on 2025-04-17
38
Participants Needed
3
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and provide signed informed consent
- Aged 18 to 55 years old, male or female
- Body weight at least 50 kg for males or 45 kg for females
- Body mass index between 19 and 28 kg/m2
- Good health based on medical history and clinical tests
- Use of highly effective contraception during the study and for 6 months (female) or 3 months (male) after dosing
You will not qualify if you...
- Participation in other clinical trials within 3 months or within 5 half-lives of investigational drug
- Positive test or history of HIV, hepatitis B or C
- Active tuberculosis or untreated latent tuberculosis infection
- History of severe herpes or zoster infection
- Serious infection, injury, or major surgery within 6 months
- History of alcohol or substance abuse or positive drug/alcohol test
- History of severe allergic or anaphylactic reactions linked to study drug components
- Any condition not suitable for participation as judged by the Investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Peking Union Medical College Hospital
Beijing, China, 100730
Not Yet Recruiting
2
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
3
The Clinical Pharmacology Research Center of PUMCH
Beijing, China
Actively Recruiting
Research Team
L
Langxi Zhang, PhD
CONTACT
T
The Clinical Pharmacology Research Center of PUMCH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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