NCT05274659

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2022

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 19, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
Last Updated

August 13, 2024

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

March 2, 2022

Last Update Submit

August 12, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Cmax

    Up to 144 hours postdose

  • Tmax

    Up to 144 hours postdose

  • t½

    Up to 144 hours postdose

  • AUC0-inf

    Up to 144 hours postdose

  • IgG level

    Day 1 through Day 63

Study Arms (6)

KJ103 dose group 1

ACTIVE COMPARATOR

KJ103 single dose

Drug: KJ103

KJ103 dose group 2

ACTIVE COMPARATOR

KJ103 single dose

Drug: KJ103

KJ103 dose group 3

ACTIVE COMPARATOR

KJ103 single dose

Drug: KJ103

KJ103 dose group 4

ACTIVE COMPARATOR

KJ103 single dose

Drug: KJ103

KJ103 dose group 5

ACTIVE COMPARATOR

KJ103 single dose

Drug: KJ103

Matching placebo for each dose group

PLACEBO COMPARATOR

placebo, single dose

Drug: Placebo

Interventions

KJ103DRUG

Recombinant Immunoglobulin G Cleaving Enzyme

Also known as: no other invention names
KJ103 dose group 1KJ103 dose group 2KJ103 dose group 3KJ103 dose group 4KJ103 dose group 5
PlaceboDRUG

Placebo

Also known as: no other invention names
Matching placebo for each dose group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Zealand Clinical Research

Auckland, 1010, New Zealand

Location

Study Officials

  • Paul Hamilton

    New Zealand Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 10, 2022

Study Start

May 19, 2022

Primary Completion

March 18, 2023

Study Completion

August 18, 2023

Last Updated

August 13, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)