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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05274659




Registration number
NCT05274659
Ethics application status
Date submitted
2/03/2022
Date registered
10/03/2022
Date last updated
13/08/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
SHBJ-2021-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KJ103
Treatment: Drugs - Placebo

Active comparator: KJ103 dose group 1 - KJ103 single dose

Active comparator: KJ103 dose group 2 - KJ103 single dose

Active comparator: KJ103 dose group 3 - KJ103 single dose

Active comparator: KJ103 dose group 4 - KJ103 single dose

Active comparator: KJ103 dose group 5 - KJ103 single dose

Placebo comparator: Matching placebo for each dose group - placebo, single dose


Treatment: Drugs: KJ103
Recombinant Immunoglobulin G Cleaving Enzyme

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AE
Timepoint [1] 0 0
Day 1 through Day 14
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Up to 144 hours postdose
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
Up to 144 hours postdose
Secondary outcome [3] 0 0
t½
Timepoint [3] 0 0
Up to 144 hours postdose
Secondary outcome [4] 0 0
AUC0-inf
Timepoint [4] 0 0
Up to 144 hours postdose
Secondary outcome [5] 0 0
IgG level
Timepoint [5] 0 0
Day 1 through Day 63

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2023
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Bao Pharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05274659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Hamilton
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05274659