Systemic Lupus ErythematosusPhase 1NCT05328557
A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
A Phase 1 study testing CUG252 in people with Systemic Lupus Erythematosus, run by Cugene Inc. at 1 site in United States.
Trial summary
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CUG252
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 3 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.
- Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray
Who cannot join
- Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
- Laboratory test results outside the local reference range and deemed clinically significant
- History of chronic medications, immunosuppressant or steroids
- History of malignant neoplasm
- History of relevant atopy
- History of hypersensitivity to biologic agents or any of the excipients in the formulation.
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- Excessive xanthine consumption
- History of drug or alcohol addiction or dependence within 1 year
- Positive of a tuberculosis test or a history of tuberculosis
- Abnormal blood pressure and/or ECG parameters
- Any prescribed medications within 28 days or nonprescription drugs within 7 days
- Previously received aldesleukin or any other IL-2 derivative
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
Read the detailed description
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CUG252, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUG252Drug
CUG252 will be administered by subcutaneous (SC) injection
PlaceboDrug
Placebo will be administered by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| CUG252 | Experimental | Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. Receives: Drug: CUG252 |
| Placebo | Placebo comparator | Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with Treatment Emergent Adverse Events
To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.
Measured: Up to 10 weeks
Secondary outcomes (6)
Pharmacokinetics profile of CUG252 (AUC)
To assess the Area under the plasma concentration versus time curve (AUC)
Measured: Up to 10 weeks
Pharmacokinetics profile of CUG252 (Cmax)
To assess the maximum plasma concentration (Cmax)
Measured: Up to 10 weeks
Pharmacokinetics profile of CUG252 (Tmax)
To assess the time of maximum concentration (Tmax)
Measured: Up to 10 weeks
Pharmacokinetics profile of CUG252 (t1/2)
To assess the half-life (t1/2)
Measured: Up to 10 weeks
Immunogenicity of CUG252
To measure the serum concentration of antibodies against CUG252
Measured: Up to 10 weeks
Change in the number and percentages of immune cells
To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start9 Nov 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cugene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin K Kankam, MD, PhD, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328557
- Sponsor's protocol ID
- CUG252-P101
- Status last verified
- Feb 2025
- First submitted
- 30 Mar 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.
- ClinicalTrials.gov ID
- NCT05328557
- Acronym / sponsor ID
- CUG252-P101
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cugene Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 14 Apr 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 intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
Detailed description
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUG252 | Experimental | Drug: CUG252Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.
- Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray
Key exclusion criteria (12 listed)
- Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
- Laboratory test results outside the local reference range and deemed clinically significant
- History of chronic medications, immunosuppressant or steroids
- History of malignant neoplasm
- History of relevant atopy
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 |
|---|---|---|
| CUG252CUG252 will be administered by subcutaneous (SC) injection | Drug | CUG252 |
| PlaceboPlacebo will be administered by subcutaneous (SC) injection | Drug | Placebo |
Primary outcome
Number and percentage of subjects with Treatment Emergent Adverse Events
Time frame: Up to 10 weeks
To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.
6 secondary outcomes
Pharmacokinetics profile of CUG252 (AUC)
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (Cmax)
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (Tmax)
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (t1/2)
Time frame: Up to 10 weeks
Immunogenicity of CUG252
Time frame: Up to 10 weeks
Change in the number and percentages of immune cells
Time frame: Up to 10 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 20 Feb 2025.
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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.
Martin K Kankam, MD, PhD principal investigator
Altasciences Company Inc.
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 CUG252 in people with Systemic Lupus Erythematosus, run by Cugene Inc. at 1 site in United States.
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 2 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 20 Feb 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 United States. 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?
Number and percentage of subjects with Treatment Emergent Adverse Events (time frame: Up to 10 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 20 Feb 2025.