Healthy Male SubjectsPhase 1NCT05559554
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
A Phase 1 study testing AK104 (before the change) and AK104 (after the change) in people with Healthy Male Subjects, run by Akeso at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- AK104 (before the change) and AK104 (after the change)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2022to 6 Apr 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 18 to 45;
- Body Mass Index (BMI) is 19.0~28.0 kg/m2, and body weight is 50.0~80.0kg ;
- Signing informed consent form before the trial and having a full understanding of the trial content, process and possible adverse reactions;
- Able to complete the study according to the requirements of the study protocol.
Who cannot join
- Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
- Those with a history of autoimmune diseases;
- Those with a history of malignant tumor, unless it is a skin squamous cell carcinoma, basal cell carcinoma or cervical cancer in situ that has been successfully resected and has no evidence of metastasis;
- Regular drinkers within 6 months prior to screening;
- Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
- Those who have used anti-PD-1/PD-L1 or/and anti-CTLA-4 drugs in the past;
Show all 12Show fewer
- Those who have been vaccinated with live or attenuated-live vaccines within 3 months before screening, or who are expected to receive vaccines during the study period;
- Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
- Those who received major surgery or hospitalization due to illness within 3 months before screening;
- Abnormal laboratory tests with clinical significance at screening;
- Positive drug screening result;
- Have a childbirth plan within 6 months from the screening period to the trial drug administration, or who are unwilling to take the contraceptive measures specified in the protocol during the trial period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Similarity of Pharmacokinetic (PK) in AK104 (a PD-1/CTLA-4 Bispecific Antibody) With Different Manufacturing Process in Healthy Chinese Male Subjects
The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.
- Conditions
- Healthy Male Subjects
- Being tested
- AK104 (before the change), AK104 (after the change)
- Keywords
- AK104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104 (before the change)Drug
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
AK104 (after the change)Drug
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
| Study group | Role | What they receive |
|---|---|---|
| AK104 (after the change) | Experimental | Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. Receives: Drug: AK104 (after the change) |
| AK104 (before the change) | Active comparator | Drug: AK104 (before the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. Receives: Drug: AK104 (before the change) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot study: Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to day 30
Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)
Measured: From pre-dose to day 29
Secondary outcomes (8)
Area under the plasma concentration-time curve (AUC0-t)
Measured: From pre-dose to day 29
Maximum plasma concentration (Cmax)
Measured: From pre-dose to day 29
Volume of distribution (Vd)
Measured: From pre-dose to day 29
Clearance (CL)
Measured: From pre-dose to day 29
Ratio of AUC0-t/AUC0-infinity
Measured: From pre-dose to day 29
Time to maximum concentration (Tmax)
Measured: From pre-dose to day 29
Half-life (t1/2)
Measured: From pre-dose to day 29
Anti-drug Antibody (ADA)
Number and percentage of subjects with detectable ADA
Measured: From pre-dose to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start25 Oct 2022
- Primary completion24 Mar 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Li, MD, Principal investigator, Changsha Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559554
- Sponsor's protocol ID
- AK104-102
- Status last verified
- May 2024
- First submitted
- 26 Sep 2022
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Similarity of Pharmacokinetic (PK) in AK104 (a PD-1/CTLA-4 Bispecific Antibody) With Different Manufacturing Process in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05559554
- Acronym / sponsor ID
- AK104-102
- Conditions
- Healthy Male Subjects
- Keywords
- AK104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 29 Sep 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.
The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK104 (after the change) | Experimental | Drug: AK104 (after the change)Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. |
| AK104 (before the change) | Active comparator | Drug: AK104 (before the change)Drug: AK104 (before the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males aged 18 to 45;
- Body Mass Index (BMI) is 19.0~28.0 kg/m2, and body weight is 50.0~80.0kg ;
- Signing informed consent form before the trial and having a full understanding of the trial content, process and possible adverse reactions;
- Able to complete the study according to the requirements of the study protocol.
Key exclusion criteria (12 listed)
- Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
- Those with a history of autoimmune diseases;
- Those with a history of malignant tumor, unless it is a skin squamous cell carcinoma, basal cell carcinoma or cervical cancer in situ that has been successfully resected and has no evidence of metastasis;
- Regular drinkers within 6 months prior to screening;
- Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
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 |
|---|---|---|
| AK104 (before the change)Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study. | Drug | AK104 (before the change) |
| AK104 (after the change)Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study. | Drug | AK104 (after the change) |
Primary outcome
Pilot study: Adverse Events (AEs)
Time frame: Up to day 30
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)
Time frame: From pre-dose to day 29
8 secondary outcomes
Area under the plasma concentration-time curve (AUC0-t)
Time frame: From pre-dose to day 29
Maximum plasma concentration (Cmax)
Time frame: From pre-dose to day 29
Volume of distribution (Vd)
Time frame: From pre-dose to day 29
Clearance (CL)
Time frame: From pre-dose to day 29
Ratio of AUC0-t/AUC0-infinity
Time frame: From pre-dose to day 29
Time to maximum concentration (Tmax)
Time frame: From pre-dose to day 29
Half-life (t1/2)
Time frame: From pre-dose to day 29
Anti-drug Antibody (ADA)
Time frame: From pre-dose to day 29
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 16 May 2024.
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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.
Xin Li, MD principal investigator
Changsha Third Hospital
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 AK104 (before the change) and AK104 (after the change) in people with Healthy Male Subjects, run by Akeso at 1 site in China.
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 12 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 16 May 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 China. 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. 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?
Pilot study: Adverse Events (AEs) (time frame: Up to day 30). The study lists 2 primary outcomes in all. 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 16 May 2024.