The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHC Biopharma Inc.

About this trial

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

Eligibility criteria

Qualifiers

1. Subjects who voluntarily participate in the study, are able to sign the informed consent form and comply with the requirements on the informed consent form;

2. Age ≥ 18 years, regardless of gender;

3. Subjects and their partners have no birth plan during the study treatment period and within 6 months after the last dose, and voluntarily use effective and reliable contraception (Attachment 1). Female subjects must have a negative serum pregnancy test and be non-lactating;

4. Patients diagnosed with SLE or CLE by the investigator

Disqualifiers

1. active severe lupus nephritis

2. active neuropsychiatric SLE

3 .History or current diagnosis of any other systemic autoimmune disease other than secondary Sjogren's syndrome, including but not limited to rheumatoid arthritis, psoriatic arthritis, dermatomyositis, systemic sclerosis (scleroderma), clinically significant non-SLE related vasculitis;

4. Drug-induced lupus;

Trial design

Treatments tested in this trial

  • HC022
  • Placebo

Treatment groups

32 Participants
are divided into 4 treatment groups

Sponsors and collaborators