Clinical trial NCT05274659: A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
Official title: A Randomized, Single-blinded, Placebo Controlled, Single Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of KJ103 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of KJ103 in healthy subjects.

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 pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.

Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 18 and 55 years, inclusive.
2. Male body weight ≥50kg, female body weight ≥45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively.
3. Immunoglobulin (IgG) levels at screening is within the normal range.
4. 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 Criteria:

1. History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency.
2. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
3. Any clinically significant illness in the 28 days prior to the first study drug administration.
4. Any history of tuberculosis.
5. Positive screening results to HIV Ag/Ab combo, syphilus, hepatitis A, hepatitis B surface antigen or hepatitis C virus tests.
6. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration.
7. Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent.
8. 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.
9. Female who is lactating.
10. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration.

Primary outcomes:
measure: AE
timeFrame: Day 1 through Day 14
Secondary outcomes:
measure: Cmax
timeFrame: Up to 144 hours postdose
measure: Tmax
timeFrame: Up to 144 hours postdose
measure: t½
timeFrame: Up to 144 hours postdose
measure: AUC0-inf
timeFrame: Up to 144 hours postdose
measure: IgG level
timeFrame: Day 1 through Day 63
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
affiliation: New Zealand Clinical Research
name: Paul Hamilton
role: PRINCIPAL_INVESTIGATOR
References: