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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05274659
• Other study ID #: SHBJ-2021-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 31, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: April 2023
• Source: Shanghai Bao Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: April 30, 2023
• Est. primary completion date: March 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• KJ103
Recombinant Immunoglobulin G Cleaving Enzyme
• Placebo
Placebo

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Bao Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

New Zealand, 

Outcome

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