TEDPhase 1/2NCT06769984
A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.
A Phase 1/2 study testing SCTT11 in people with TED, run by Sinocelltech Ltd..
Trial summary
Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- TED
- What is being tested?
- SCTT11
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2025to 19 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female participants aged between18 and 45 inclusive
- All participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding
- Male or female participants aged between 18 and 70 inclusive
- Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED
- Normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine [FT3] and free thyroxine [FT4] levels < 50% above or below the normal limits).
Who cannot join
- 1.With any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological/psychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator.
- Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
- Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator
- A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period
- Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results
- Presence of poorly controlled diabetes mellitus
Show all 15Show fewer
- The current presence of other uncontrolled clinical diseases or conditions
- Abnormalities in any of the following laboratory examinations during the screening phase
- Poorly controlled hypertension
- With past medical histories of major surgery and/or trauma within 1 month prior to the first dose
- With past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product
- Vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study
- Participation in a clinical study of any drug or device within 3 months prior to the first dose and have used the investigational product or have been treated with the device
- Pregnant, lactating females; or participants of childbearing potential who are unwilling to use effective contraception during the study and within 180 days after the last dose
- Other conditions evaluated by the investigator to be unsuitable for enrolment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Moderate-to-severe Thyroid Eye Disease
Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease
- Conditions
- TED
- Being tested
- SCTT11, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTT11Drug
SCTT11 dose 1, dose 2, dose 3, dose 4
PlaceboDrug
Placebo dose 1, dose 2, dose 3, dose 4
| Study group | Role | What they receive |
|---|---|---|
| SCTT11 dose 1, dose 2, dose 3, dose 4 | Experimental | Not described Receives: Drug: SCTT11 |
| Placebo dose 1, dose 2, dose 3, dose 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI)
Measured: Day 0 up to 85 days for healthy participants
Proptosis Responder Rate in the study eye
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer)
Measured: Day 0 up to 169 days
Secondary outcomes (6)
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Measured: Day 0 up to 169days
Change from baseline in Clinical Activity Score (CAS)
Measured: Day 0 up to 169days
Diplopia Responder Rate
Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score >0)
Measured: Day 0 up to 169days
Proportion of participants with a CAS of zero or one in the study eye
Measured: Day 0 up to 169days
SCTT11 concentrations in the blood over time
Measured: Day 0 up to 169days
Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time
Measured: Day 0 up to 169days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start19 Feb 2025 (estimated)
- Primary completion24 Jun 2026 (estimated)
- Study completion19 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TEDStudies of the same condition, open and under way.
- More trials run by Sinocelltech 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769984
- Sponsor's protocol ID
- SCTT11-X201
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Moderate-to-severe Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06769984
- Acronym / sponsor ID
- SCTT11-X201
- Conditions
- TED
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2025 (estimated)
- Primary completion
- 24 Jun 2026 (estimated)
- Study completion
- 19 Sep 2028 (estimated)
- First posted
- 10 Jan 2025 (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.
Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTT11 dose 1, dose 2, dose 3, dose 4 | Experimental | Drug: SCTT11 |
| Placebo dose 1, dose 2, dose 3, dose 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female participants aged between18 and 45 inclusive
- All participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding
- Male or female participants aged between 18 and 70 inclusive
- Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED
- Normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine [FT3] and free thyroxine [FT4] levels < 50% above or below the normal limits).
Key exclusion criteria (15 listed)
- 1.With any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological/psychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator.
- Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
- Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator
- A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period
- Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results
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 |
|---|---|---|
| SCTT11SCTT11 dose 1, dose 2, dose 3, dose 4 | Drug | SCTT11 dose 1, dose 2, dose 3, dose 4 |
| PlaceboPlacebo dose 1, dose 2, dose 3, dose 4 | Drug | Placebo dose 1, dose 2, dose 3, dose 4 |
Primary outcome
The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI)
Time frame: Day 0 up to 85 days for healthy participants
Proptosis Responder Rate in the study eye
Time frame: Day 0 up to 169 days
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer)
6 secondary outcomes
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Time frame: Day 0 up to 169days
Change from baseline in Clinical Activity Score (CAS)
Time frame: Day 0 up to 169days
Diplopia Responder Rate
Time frame: Day 0 up to 169days
Proportion of participants with a CAS of zero or one in the study eye
Time frame: Day 0 up to 169days
SCTT11 concentrations in the blood over time
Time frame: Day 0 up to 169days
Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time
Time frame: Day 0 up to 169days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCTT11 in people with TED, run by Sinocelltech Ltd..
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 5 inclusion and 15 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: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Guo (+86-10-58628288-9127, ming_guo@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI) (time frame: Day 0 up to 85 days for healthy participants). 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 10 Jan 2025.