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

Recruiting Phase 1 Interventional Study
Systemic Lupus Erythematosus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
HC Biopharma Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements; 2. Aged 18 to 55 years old, inclusive, male or female; 3. 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must…
Contacts

Langxi Zhang, PhD

8602150433368

langxi.zhang@btyy.com

CONTACT

The Clinical Pharmacology Research Center of PUMCH

CONTACT