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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-19

Study Completion Date

2023-08-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

NCT00972049

Healthy

COMPLETED PHASE1

Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..

NCT05955183

Healthy Participants

COMPLETED PHASE1

A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 in Japanese Healthy Participants

NCT02016066

Healthy

WITHDRAWN PHASE1

A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

NCT05703841

Healthy

COMPLETED PHASE1

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants

NCT02398591

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KJ103 dose group 1

KJ103 single dose

Group Type ACTIVE_COMPARATOR

KJ103

Intervention Type DRUG

Recombinant Immunoglobulin G Cleaving Enzyme

KJ103 dose group 2

KJ103 single dose

Group Type ACTIVE_COMPARATOR

KJ103

Intervention Type DRUG

Recombinant Immunoglobulin G Cleaving Enzyme

KJ103 dose group 3

KJ103 single dose

Group Type ACTIVE_COMPARATOR

KJ103

Intervention Type DRUG

Recombinant Immunoglobulin G Cleaving Enzyme

KJ103 dose group 4

KJ103 single dose

Group Type ACTIVE_COMPARATOR

KJ103

Intervention Type DRUG

Recombinant Immunoglobulin G Cleaving Enzyme

KJ103 dose group 5

KJ103 single dose

Group Type ACTIVE_COMPARATOR

KJ103

Intervention Type DRUG

Recombinant Immunoglobulin G Cleaving Enzyme

Matching placebo for each dose group

placebo, single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KJ103

Recombinant Immunoglobulin G Cleaving Enzyme

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

no other invention names no other invention names

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes