A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: KJ103

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1010
    • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching placebo for each dose group; placebo, single dose	Drug: Placebo; Placebo; Other Names: no other invention names
Active Comparator: KJ103 dose group 1; KJ103 single dose	Drug: KJ103; Recombinant Immunoglobulin G Cleaving Enzyme; Other Names: no other invention names
Active Comparator: KJ103 dose group 2; KJ103 single dose	Drug: KJ103; Recombinant Immunoglobulin G Cleaving Enzyme; Other Names: no other invention names
Active Comparator: KJ103 dose group 3; KJ103 single dose	Drug: KJ103; Recombinant Immunoglobulin G Cleaving Enzyme; Other Names: no other invention names
Active Comparator: KJ103 dose group 4; KJ103 single dose	Drug: KJ103; Recombinant Immunoglobulin G Cleaving Enzyme; Other Names: no other invention names
Active Comparator: KJ103 dose group 5; KJ103 single dose	Drug: KJ103; Recombinant Immunoglobulin G Cleaving Enzyme; Other Names: no other invention names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug	Day 1 through Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	The maximum measured concentration of the analysis in serum	Up to 144 hours postdose
Tmax	Time To Reach The Maximal serum Concentration	Up to 144 hours postdose
t½	Terminal Elimination Half-Life	Up to 144 hours postdose
AUC0-inf	Area Under the Serum Concentration Versus Time Curve From Zero to Infinity	Up to 144 hours postdose
IgG level	Concentration of Immunoglobulin G in serum	Day 1 through Day 63

Collaborators and Investigators

• Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Paul Hamilton, New Zealand Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): March 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHBJ-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No