Graves DiseasePhase 1NCT07305818
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
A Phase 1 study testing MER511 (IV), MER511 (SC) and MER511 (SC) for MAD in people with Graves Disease, run by Merida Biosciences at 16 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- MER511 (IV), MER511 (SC) and MER511 (SC) for MAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 19 Dec 2025to 24 Jul 2028
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 65 years of age, inclusive, at the time of signing the ICF
- Documented GD diagnosis,
- Receiving stable dose of ATD (Antithyroid drug)
- Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive
- Women of childbearing potential must agree to use highly effective contraceptive methods
- Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence
- Signed informed consent to participate in the study
- Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments).
Who cannot join
- History of:
- total thyroidectomy.
- History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter).
- History of thyroid storm.
- History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity due to prior ATD therapy Treatment with RAI therapy within 12 months prior to Screening
- Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis.
Show all 37Show fewer
- Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening.
- Current active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening
- History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation within 3 months prior to Screening, or per required prohibited concomitant therapy washout criteria in the protocol (whichever is longer)
- Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing.
- Active systemic autoimmune disease requiring treatment that causes undue risk in the opinion of the investigator.
- History of cardiovascular, respiratory, renal, gastrointestinal, endocrinological (other than GD), hematological, immunodeficiency, or neurological disorders that may constitute a risk when taking the IMP or interfere with data interpretation.
- History of liver disease
- Pregnant, breastfeeding, or planning to become pregnant during the study
- Treatment with prohibited medications prior to planned IMP dosing or likely to require prohibited concomitant therapy during the study
- Live vaccine(s) or mRNA vaccine(s) within 1 month prior to IMP dosing, or plans to receive such vaccines during the study
- Treatment with any investigational drug within within 3 months or 5 half-lives (whichever is longer) prior to enrollment
- Total IgG level <700 mg/dL at Screening
- Any of the following at Screening (confirmed by single repeat measurement, if deemed necessary):
- ALT or AST >1.5 × ULN
- Total bilirubin >1.5 × ULN
- Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- Positive result for HIV antibody, HBsAg, or hepatitis C antibody with detectable viral RNA levels at Screening
- Positive drug screen or positive test for alcohol
- 12-lead ECG demonstrating any of the following at Screening:
- QTcF interval >450 ms
- QRS interval >120 ms
- PR interval >220 ms
- Blood pressure measurements demonstrating any of the following at Screening:
- Systolic blood pressure ≥140 mmHg
- Diastolic blood pressure ≥90 mmHg
- Heart rate <45 bpm or >100 bpm
- Donated more than 500 mL of blood in the 2 months prior to signing the ICF
- Current enrollment or past participation within 3 months or 5 half-lives (whichever is longer) prior to signing the ICF in any other clinical trial involving an IMP
- Refusal to adhere to lifestyle considerations as defined in the protocol
- Employee of the investigator, clinic, or sponsor with direct involvement in the proposed study or other studies under the direction of the investigator or clinic, as well as family members of the employee or investigator
- Any other conditions that, in the opinion of the investigator or the sponsor, could interfere with participation in or completion of the study
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Site # 1107
Boston, Massachusetts, 02114
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1104
Columbus, Ohio, 43203
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1113
DeSoto, Texas, 75115
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1101
Hollywood, Florida, 33024
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1112
Miami, Florida, 33125
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1106
Morehead City, North Carolina, 28557
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1108
Philadelphia, Pennsylvania, 19107
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1102
Rochester, Minnesota, 55905
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1111
Torrance, California, 90502
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1105
Webster, Texas, 77598
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 1109
Wesley Chapel, Florida, 33544
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
Spain5 sites, 5 recruiting
- Recruiting
Site # 2205
A Coruña, 15006
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 2204
Barcelona, 08017
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 2206
Barcelona, 08023
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 2202
Santander, 39008
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
- Recruiting
Site # 2201
Seville, 41009
Principal Investigator, 339-255-3030, clinicaltrials@meridabio.com
About this study
Official title: A Phase 1, First-in-Human, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous Administration of MER511 in Adults With Graves' Disease
The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Read the detailed description
This Phase 1, first-in-human, multicenter study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single and multiple ascending doses of MER511 administered to adults (18 to 65 years of age, inclusive) with GD (Graves' disease).
The study will consist of 2 sequential parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
Part A will employ a placebo-controlled, sponsor-open, participant- and investigator-blind design to evaluate the safety, tolerability, PK, PD, and immunogenicity of single ascending intravenous doses and a single subcutaneous dose of MER511.
Part B will employ a placebo-controlled, sponsor-open, participant- and investigator-blind design to assess the safety, tolerability, PK, PD, and immunogenicity of multiple subcutaneous doses of MER511.
- Conditions
- Graves Disease
- Being tested
- MER511 (IV), Placebo comparator (IV), MER511 (SC), Placebo comparator (SC), MER511 (SC) for MAD
- Keywords
- Graves' Disease, Hyperthyroidism, Basedow disease, Exophthalmic goitre, TSHR, Autoimmune, Anti-thyroid drugs, Autoimmune thyroid disease
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MER511 (IV)Biological
Participants will receive a single dose of MER511 on Day 1
Placebo comparator (IV)Biological
Participants will receive a single dose of Placebo on Day 1
MER511 (SC)Biological
Participants will receive a single dose of MER511 on Day 1
Placebo comparator (SC)Biological
Participants will receive a single dose of Placebo on Day 1
MER511 (SC) for MADBiological
Participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29
Placebo comparator (SC) for MADBiological
Participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29
| Study group | Role | What they receive |
|---|---|---|
| Part A (SAD) MER511 IV | Experimental | For Cohorts 1-7 , each cohort participant will receive a single ascending dose of MER511 via IV administration on Day 1 Receives: Biological: MER511 (IV) |
| Part A (SAD) placebo IV | Placebo comparator | For Cohorts 1-7, each cohort participant will receive a single dose of placebo via IV administration on Day 1 Receives: Biological: Placebo comparator (IV) |
| Part A (SAD) MER511 SC | Experimental | For Cohort 8, participants will receive a single dose of MER511 (determined from Cohort 1-7) via SC administration on Day 1 Receives: Biological: MER511 (SC) |
| Part A (SAD) placebo SC | Placebo comparator | For Cohort 8, participants will receive a single dose of placebo (determined from Cohort 1-7) via SC administration on Day 1 Receives: Biological: Placebo comparator (SC) |
| Part B (MAD) MER511 SC | Experimental | Up to 3 cohorts of participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29 Receives: Biological: MER511 (SC) for MAD |
| - Part B (MAD) placebo SC | Placebo comparator | Up to 3 cohorts of participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29 Receives: Biological: Placebo comparator (SC) for MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with TEAEs (Treatment-emergent adverse events)
Adverse events that start or worsen in severity after the start of study drug will be categorized as TEAEs
Measured: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination
Incidence of clinically significant abnormalities in ECGs, vital signs, clinical laboratory values, and physical examination
Measured: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
Secondary outcomes (5)
Serum Cmax (Maximum observed concentration)
Measurement of the maximum observed concentration
Measured: - Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) through Week 16- Part B (MAD) Cohorts: Day 1 (Week 0 dosing Day) Through Week 24
Serum tmax (Time to maximum concentration)
Measurement of the time to maximum observed concentration
Measured: - Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 16 - Part B (MAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 24
Serum AUCinf (area under concentration-time curve from time zero to infinity)
Measurement of area under concentration-time curve from time zero to infinity
Measured: Part A (SAD) Only: Day 1 (Week 0) Dosing Through Week 16
Serum AUC0-tau (area under concentration-time curve during the dosing interval)
Measurement of area under concentration-time curve during the dosing interval
Measured: Part B (MAD) Only: Day 1 (Week 0) Dosing Through Week 24
Number of participants with ADAs (Anti-drug antibody)
Blood samples will be collected to evaluate the immunogenicity of MER511 in participants with GD (Graves' disease)
Measured: - Part A (SAD) Cohorts: Day 1 (Week 0) Dosing Through Week 16 or Early Discontinuation - Part B (MAD) Cohorts: Day 1 (Week 0) Dosing Through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start19 Dec 2025
- Primary completion24 Jul 2028 (estimated)
- Study completion24 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies 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
- Sequential
- Model description
- The study will enroll cohorts of participants who will be assigned to a dose group for Part A and Part B.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merida Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305818
- Sponsor's protocol ID
- MER511-1001
- Other IDs
- 2025-523823-23-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous Administration of MER511 in Adults With Graves' Disease
- ClinicalTrials.gov ID
- NCT07305818
- Acronym / sponsor ID
- MER511-1001
- Conditions
- Graves Disease
- Keywords
- Graves' Disease, Hyperthyroidism, Basedow disease, Exophthalmic goitre, TSHR, Autoimmune, Anti-thyroid drugs, Autoimmune thyroid disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Merida BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 24 Jul 2028 (estimated)
- Study completion
- 24 Jul 2028 (estimated)
- First posted
- 26 Dec 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.
The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Detailed description
This Phase 1, first-in-human, multicenter study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single and multiple ascending doses of MER511 administered to adults (18 to 65 years of age, inclusive) with GD (Graves' disease).
The study will consist of 2 sequential parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
Part A will employ a placebo-controlled, sponsor-open, participant- and investigator-blind design to evaluate the safety, tolerability, PK, PD, and immunogenicity of single ascending intravenous doses and a single subcutaneous dose of MER511.
Part B will employ a placebo-controlled, sponsor-open, participant- and investigator-blind design to assess the safety, tolerability, PK, PD, and immunogenicity of multiple subcutaneous doses of MER511.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- The study will enroll cohorts of participants who will be assigned to a dose group for Part A and Part B.
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD) MER511 IV | Experimental | Biological: MER511 (IV)For Cohorts 1-7 , each cohort participant will receive a single ascending dose of MER511 via IV administration on Day 1 |
| Part A (SAD) placebo IV | Placebo comparator | Biological: Placebo comparator (IV)For Cohorts 1-7, each cohort participant will receive a single dose of placebo via IV administration on Day 1 |
| Part A (SAD) MER511 SC | Experimental | Biological: MER511 (SC)For Cohort 8, participants will receive a single dose of MER511 (determined from Cohort 1-7) via SC administration on Day 1 |
| Part A (SAD) placebo SC | Placebo comparator | Biological: Placebo comparator (SC)For Cohort 8, participants will receive a single dose of placebo (determined from Cohort 1-7) via SC administration on Day 1 |
| Part B (MAD) MER511 SC | Experimental | Biological: MER511 (SC) for MADUp to 3 cohorts of participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29 |
| - Part B (MAD) placebo SC | Placebo comparator | Biological: Placebo comparator (SC) for MADUp to 3 cohorts of participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 18 to 65 years of age, inclusive, at the time of signing the ICF
- Documented GD diagnosis,
- Receiving stable dose of ATD (Antithyroid drug)
- Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive
- Women of childbearing potential must agree to use highly effective contraceptive methods
Key exclusion criteria (37 listed)
- History of:
- Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis.
- Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening.
- Current active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening
- History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation within 3 months prior to Screening, or per required prohibited concomitant therapy washout criteria in the protocol (whichever is longer)
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 |
|---|---|---|
| MER511 (IV)Participants will receive a single dose of MER511 on Day 1 | Biological | Part A (SAD) MER511 IV |
| Placebo comparator (IV)Participants will receive a single dose of Placebo on Day 1 | Biological | Part A (SAD) placebo IV |
| MER511 (SC)Participants will receive a single dose of MER511 on Day 1 | Biological | Part A (SAD) MER511 SC |
| Placebo comparator (SC)Participants will receive a single dose of Placebo on Day 1 | Biological | Part A (SAD) placebo SC |
| MER511 (SC) for MADParticipants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29 | Biological | Part B (MAD) MER511 SC |
| Placebo comparator (SC) for MADParticipants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29 | Biological | - Part B (MAD) placebo SC |
Primary outcome
Number of participants with TEAEs (Treatment-emergent adverse events)
Time frame: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
Adverse events that start or worsen in severity after the start of study drug will be categorized as TEAEs
Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination
Time frame: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
Incidence of clinically significant abnormalities in ECGs, vital signs, clinical laboratory values, and physical examination
5 secondary outcomes
Serum Cmax (Maximum observed concentration)
Time frame: - Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) through Week 16- Part B (MAD) Cohorts: Day 1 (Week 0 dosing Day) Through Week 24
Serum tmax (Time to maximum concentration)
Time frame: - Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 16 - Part B (MAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 24
Serum AUCinf (area under concentration-time curve from time zero to infinity)
Time frame: Part A (SAD) Only: Day 1 (Week 0) Dosing Through Week 16
Serum AUC0-tau (area under concentration-time curve during the dosing interval)
Time frame: Part B (MAD) Only: Day 1 (Week 0) Dosing Through Week 24
Number of participants with ADAs (Anti-drug antibody)
Time frame: - Part A (SAD) Cohorts: Day 1 (Week 0) Dosing Through Week 16 or Early Discontinuation - Part B (MAD) Cohorts: Day 1 (Week 0) Dosing Through Week 24
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 30 Sep 2026.
- 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.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MER511 (IV), MER511 (SC) and MER511 (SC) for MAD in people with Graves Disease, run by Merida Biosciences at 16 sites in 2 countries.
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 8 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Spain. 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?
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 Clinical Operations (+1 339-255-3030, clinicaltrials@meridabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with TEAEs (Treatment-emergent adverse events) (time frame: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24). 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 30 Sep 2026.