HealthyPhase 1NCT05274659
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
A Phase 1 study testing KJ103 in people with Healthy, run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KJ103
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteNew Zealand
- Study dates
- 19 May 2022to 18 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- KJ103, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KJ103Drug
Also called no other invention names
Recombinant Immunoglobulin G Cleaving Enzyme
PlaceboDrug
Also called no other invention names
Placebo
| Study group | Role | What they receive |
|---|---|---|
| KJ103 dose group 1 | Active comparator | KJ103 single dose Receives: Drug: KJ103 |
| KJ103 dose group 2 | Active comparator | KJ103 single dose Receives: Drug: KJ103 |
| KJ103 dose group 3 | Active comparator | KJ103 single dose Receives: Drug: KJ103 |
| KJ103 dose group 4 | Active comparator | KJ103 single dose Receives: Drug: KJ103 |
| KJ103 dose group 5 | Active comparator | KJ103 single dose Receives: Drug: KJ103 |
| Matching placebo for each dose group | Placebo comparator | placebo, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 through Day 14
Secondary outcomes (5)
Cmax
The maximum measured concentration of the analysis in serum
Measured: Up to 144 hours postdose
Tmax
Time To Reach The Maximal serum Concentration
Measured: Up to 144 hours postdose
t½
Terminal Elimination Half-Life
Measured: Up to 144 hours postdose
AUC0-inf
Area Under the Serum Concentration Versus Time Curve From Zero to Infinity
Measured: Up to 144 hours postdose
IgG level
Concentration of Immunoglobulin G in serum
Measured: Day 1 through Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start19 May 2022
- Primary completion18 Mar 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Hamilton, Principal investigator, New Zealand Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274659
- Sponsor's protocol ID
- SHBJ-2021-001
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05274659
- Acronym / sponsor ID
- SHBJ-2021-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| KJ103 dose group 1 | Active comparator | Drug: KJ103KJ103 single dose |
| KJ103 dose group 2 | Active comparator | Drug: KJ103KJ103 single dose |
| KJ103 dose group 3 | Active comparator | Drug: KJ103KJ103 single dose |
| KJ103 dose group 4 | Active comparator | Drug: KJ103KJ103 single dose |
| KJ103 dose group 5 | Active comparator | Drug: KJ103KJ103 single dose |
| Matching placebo for each dose group | Placebo comparator | Drug: Placeboplacebo, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KJ103Also: no other invention namesRecombinant Immunoglobulin G Cleaving Enzyme | Drug | KJ103 dose group 1, KJ103 dose group 2, KJ103 dose group 3, KJ103 dose group 4, KJ103 dose group 5 |
| PlaceboAlso: no other invention namesPlacebo | Drug | Matching placebo for each dose group |
Primary outcome
AE
Time frame: Day 1 through Day 14
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
5 secondary outcomes
Cmax
Time frame: Up to 144 hours postdose
Tmax
Time frame: Up to 144 hours postdose
t½
Time frame: Up to 144 hours postdose
AUC0-inf
Time frame: Up to 144 hours postdose
IgG level
Time frame: Day 1 through Day 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Hamilton principal investigator
New Zealand Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KJ103 in people with Healthy, run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: Day 1 through Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.