Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
Lead Sponsor:
Shanghai Bao Pharmaceuticals Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity o...
Detailed Description
This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodyn...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 and 55 years, inclusive.
- Male body weight ≥50kg, female body weight ≥45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively.
- Immunoglobulin (IgG) levels at screening is within the normal range.
- Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, biochemistry, and urinalysis.
Exclusion
- History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency.
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
- Any clinically significant illness in the 28 days prior to the first study drug administration.
- Any history of tuberculosis.
- Positive screening results to HIV Ag/Ab combo, syphilus, hepatitis A, hepatitis B surface antigen or hepatitis C virus tests.
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration.
- Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent.
- Received an investigational drug (or was using an investigational device at the time) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer.
- Female who is lactating.
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05274659
Start Date
May 19 2022
End Date
August 18 2023
Last Update
August 13 2024
Active Locations (1)
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1
New Zealand Clinical Research
Auckland, New Zealand, 1010