Interstitial Lung DiseasePhase 1NCT05894148
Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults
A Phase 1 study testing Genakumab injection in people with Interstitial Lung Disease, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Genakumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2023to 30 Nov 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years ≤ age ≤45 years, and in good health;
- body mass index is within the range of 19 - 26 kg/m^2 (including 19 kg/m^2 and 26 kg/m^2);
- No parental scheme from the screening period to 3 months after the study period.
Who cannot join
- Participants have abnormal physical and auxiliary examination results with clinical significance;
- History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders,
- Participants who use any prescription drugs within 2 weeks prior dosing.
- Participants who receive (attenuated) live vaccines within 3 months prior to dosing;
- Participation in any clinical investigation within 3 months prior to dosing;
- Donation or loss of 400 mL or more of blood within 3 months prior to dosing;
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- Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
- Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
- Current or previous drug or alcohol abuse;
- Other conditions in which the investigator preclude enrollment into the study
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
Chengdu, Sichuan
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
Read the detailed description
There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.
- Conditions
- Interstitial Lung Disease
- Being tested
- Genakumab injection, placebo
- Keywords
- Safety,, Tolerability,, Pharmacokinetics,, Genakumab
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genakumab injectionDrug
Group 1: 120mg Q4W，group 2: 200mg Q4W
placeboDrug
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.
| Study group | Role | What they receive |
|---|---|---|
| Genakumab injection | Experimental | Group 1: 120mg，group 2: 200mg Receives: Drug: Genakumab injection |
| placebo | Placebo comparator | The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of adverse events (AE)
adverse events during the study are to assess the safety of Genakumab.
Measured: Up to 20 weeks
Secondary outcomes (2)
Maximum observed serum Genakumab concentration
This is to assess pharma co kinetics of Genakumab.
Measured: up to 20 weeks
Area under the serum Genakumab concentration-time curve
This is to assess pharma co kinetics of Genakumab.
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start6 Mar 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of North Sichuan Medical College
- Responsible party
- Sponsor
- Investigators
- Xiaolan Yong, bachelor, Study chair, Chengdu Xinhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894148
- Sponsor's protocol ID
- GenSci048-102
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
- ClinicalTrials.gov ID
- NCT05894148
- Acronym / sponsor ID
- GenSci048-102
- Conditions
- Interstitial Lung Disease
- Keywords
- Safety,, Tolerability,, Pharmacokinetics,, Genakumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of North Sichuan Medical College
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Jun 2023 (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.
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
Detailed description
There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genakumab injection | Experimental | Drug: Genakumab injectionGroup 1: 120mg，group 2: 200mg |
| placebo | Placebo comparator | Drug: placeboThe placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years ≤ age ≤45 years, and in good health;
- body mass index is within the range of 19 - 26 kg/m^2 (including 19 kg/m^2 and 26 kg/m^2);
- No parental scheme from the screening period to 3 months after the study period.
Key exclusion criteria (10 listed)
- Participants have abnormal physical and auxiliary examination results with clinical significance;
- History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders,
- Participants who use any prescription drugs within 2 weeks prior dosing.
- Participants who receive (attenuated) live vaccines within 3 months prior to dosing;
- Participation in any clinical investigation within 3 months prior to dosing;
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 |
|---|---|---|
| Genakumab injectionGroup 1: 120mg Q4W，group 2: 200mg Q4W | Drug | Genakumab injection |
| placeboThe placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection. | Drug | placebo |
Primary outcome
The frequency of adverse events (AE)
Time frame: Up to 20 weeks
adverse events during the study are to assess the safety of Genakumab.
2 secondary outcomes
Maximum observed serum Genakumab concentration
Time frame: up to 20 weeks
Area under the serum Genakumab concentration-time curve
Time frame: up to 20 weeks
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 1 Apr 2025.
- 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.
Xiaolan Yong, bachelor study chair
Chengdu Xinhua 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 Genakumab injection in people with Interstitial Lung Disease, run by Changchun GeneScience Pharmaceutical Co., Ltd. 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 3 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 1 Apr 2025. 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. 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?
The frequency of adverse events (AE) (time frame: Up to 20 weeks). 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 1 Apr 2025.