MASHPhase 1NCT06485245
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects
A Phase 1 study testing CS060304 in people with MASH, run by Cascade Pharmaceuticals, Inc at 1 site in China.
Trial summary
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MASH
- What is being tested?
- CS060304
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 1 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SAD
- Sign and date the ICF.
- Signing ICF age≥18 years≤55 years, male or female.
- Weight: Male≥50kg, female≥45kg BMI: 18~28kg/m².
- Female or male subjects must be eligible for contraception during the study and for three months after the last dose.
- Normal renal function.
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- Good general health.
- No significant medical history, in good general health as assessed by the study during the Screening Period and no more than 28 days from the first dose.
- Understand and comply with study procedures and limitations.
- MAD
- Sign and date the ICF.
- Signing ICF age≥18 years≤65 years, male or female.
- Weight: Male≥50kg, female≥45kg BMI: 18~35kg/m².
- Screening period, fasting LDL-C > 110 mg/dL (2.85 mmol/L).
- Female or male subjects must be eligible for contraception during the study and for three months after the last dose.
- Normal renal function.
- Good general health.
- No significant medical history, in good general health as assessed by the study during the Screening Period and no more than 28 days from the first dose.
- Understand and comply with study procedures and limitations. -
Who cannot join
- SAD
- Special dietary requirements, not following a uniform diet.
- Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
- History of febrile illness or active infection within 7 days prior to first dose.
- Positive urine drug screens at screening or baseline.
- History of substance/drug abuse in the 5 years prior to the start of the trial, or a positive screening or baseline drug screen result.
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- History of previous corrected QT interval (QTc) prolongation:
- Screening periods QTcF ≥ 450 ms.
- Family history of hypocalcaemia or long QT interval syndrome.
- Use of drugs causing QT/QTc prolongation.
- Investigator judgement of clinically significant abnormal ECG results.
- Abnormal liver function: AST, ALT, ALP, GGT and TBIL>ULN.
- Smoking or use of nicotine products within 3 months prior to screening and during the study period.
- Use of other investigational drugs 40 days prior to enrolment or within at least 5 half-lives of drug use.
- Positive screening results for infectious diseases during the screening period, include HIV, HBsAg, HBcAb, HCV antibody tests.
- Any abnormal results of laboratory tests judged by the investigator to be clinically significant during the screening period.
- Blood loss within 40 days prior to administration 50~500 mL, or loss of more than 500 mL of blood within 56 days prior to administration.
- Men and women who consumed more than 1 unit per day prior to screening. [1 unit = 150 ml of wine, 360 ml of beer or 45 ml of 40% alcohol]. Subjects will not be permitted to consume alcohol 48 hours prior to dosing and while in the CRU.
- Prescription and over-the-counter use within 14 days or at least 5 half-lives prior to the baseline period, or use of any drug or other substance that may affect CYP3A activity within 14 days or at least 5 half-lives before taking this study drug.
- History of thyroid disease or clinically significant thyroid test abnormalities.
- Allergy to thyroid medication.
- Presence of any disease that may interfere with the absorption, distribution, metabolism or excretion of drugs, Including bile salt metabolism in the colon, such as gastrectomy, inflammatory bowel disease, etc.
- According to the researcher's judgment, there are clinically significant diseases found, including but not limited to (gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases), researchers believe that participating in the study poses risks to participants.
- Allergy to the investigational drug or any component of the investigational drug, Allergy history and constitution.
- Diseases or conditions with clinical significance that researchers believe may pose a risk to the safety of subjects or interfere with the conduct, progress, or completion of the study.
- Abnormal thyroid function test during screening.
- Screening or baseline cardiac troponin>ULN.
- MAD
- Special dietary requirements that cannot follow a unified diet.
- Pregnant or lactating women who have a pregnancy plan during or within 3 months after the trial, female subjects tested positive for pregnancy during screening or baseline period.
- Individuals with a history of febrile diseases or active infections within 7 days prior to the first administration of medication.
- Positive urine drug screening results during screening or baseline period.
- History of drug/drug abuse within 5 years prior to the start of the trial, or positive drug screening results during screening or baseline period.
- Subjects who are receiving lipid-lowering treatment or have LDL-C>190 mg/dL and have a family history of coronary heart disease, arrhythmia, unexplained syncope, or cardiac arrest.
- Existing history of QTc extension in the past:
- Screening period QTcF ≥ 450 ms.
- Family history of hypocalcemia or long QT interval syndrome.
- Using drugs that cause QT/QTc prolongation.
- Abnormal results of ECG with clinical significance determined by researchers.
- Abnormal liver function: AST, ALT, ALP, GGT and TBIL>ULN.
- Screening for smoking or using nicotine products within the first 3 months and during the study period.
- Use of other investigational drugs 40 days prior to enrolment or within at least 5 half-lives of drug use.
- Positive screening results for infectious diseases during the screening period, include HIV, HBsAg, HBcAb, HCV antibody Tests.
- Any abnormal results of laboratory tests judged by the investigator to be clinically significant during the screening period.
- Blood loss within 40 days prior to administration 50~500 mL, or loss of more than 500 mL of blood within 56 days prior to administration.
- Men and women who consumed more than 1 unit per day prior to screening. [1 unit = 150 ml of wine, 360 ml of beer or 45 ml of 40% alcohol]. Subjects will not be permitted to consume alcohol 48 hours prior to dosing and while in the CRU.
- Prescription and over-the-counter use within 14 days or at least 5 half-lives prior to the baseline period, or use of any drug or other substance that may affect CYP3A activity within 14 days or at least 5 half-lives before taking this study drug.
- History of thyroid disease or clinically significant thyroid test abnormalities.
- Allergy to thyroid medication.
- Presence of any disease that may interfere with the absorption, distribution, metabolism or excretion of drugs, Including bile salt metabolism in the colon, such as gastrectomy, inflammatory bowel disease, etc.
- According to the researcher's judgment, there are clinically significant diseases found, including but not limited to (gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases), researchers believe that participating in the study poses risks to participants.
- Allergy to the investigational drug or any component of the investigational drug, Allergy history and constitution.
- Diseases or conditions with clinical significance that researchers believe may pose a risk to the safety of subjects or interfere with the conduct, progress, or completion of the study.
- Abnormal thyroid function test during screening.
- Screening or baseline cardiac troponin>ULN.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect of Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalations of CS060304 in Healthy and Elevated LDL-C Subjects
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects.
Read the detailed description
A Phase I study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effects of Randomised, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalations of CS060304 in Healthy and Elevated LDL-C Subjects.
- Conditions
- MASH
- Being tested
- CS060304
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS060304Drug
Also called Pleacbo
Tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: 0.2mg CS060304 | Experimental | Healthy subjects in a fasting state will receive a single dose of CS060304 0.2 mg or placebo. Receives: Drug: CS060304 |
| Cohort A2: 1mg CS060304 | Experimental | Healthy subjects in a fasting state will receive a single dose of CS060304 1 mg or placebo. Receives: Drug: CS060304 |
| Cohort A3: 4mg CS060304 | Experimental | Healthy subject in fasted state receive a single oral dose of CS060304 4 mg or placebo on day 1, followed by a 4 day washout period, subjects in fed state will receive the same single oral dose of CS060304 4mg or placebo on day 5. Receives: Drug: CS060304 |
| Cohort A4: 10mg CS060304 | Experimental | Healthy subjects in a fasting state will receive a single dose of CS060304 10 mg or placebo. Receives: Drug: CS060304 |
| Cohort A5: 20mg CS060304 | Experimental | Healthy subjects in a fasting state will receive a single dose of CS060304 20 mg or placebo. Receives: Drug: CS060304 |
| Cohort A6: 40mg CS060304 | Experimental | Healthy subjects in a fasting state will receive a single dose of CS060304 40 mg or placebo. Receives: Drug: CS060304 |
| Cohort B1: 2mg CS060304 | Experimental | Elevated LDL-C subjects will receive the CS060304 2 mg or placebo once daily for a consecutive 14 days. Receives: Drug: CS060304 |
| Cohort B2: 5mg CS060304 | Experimental | Elevated LDL-C subjects will receive the CS060304 5 mg or placebo once daily for a consecutive 14 days. Receives: Drug: CS060304 |
| Cohort B3: 10mg CS060304 | Experimental | Elevated LDL-C subjects will receive the CS060304 10 mg or placebo once daily for a consecutive 14 days. Receives: Drug: CS060304 |
| Cohort B4: 20mg CS060304 | Experimental | Elevated LDL-C subjects will receive the CS060304 20 mg or placebo once daily for a consecutive 14 days. Receives: Drug: CS060304 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Physical examination, vital signs, including blood pressure, pulse, respiratory rate, and body temperature, 12 lead electrocardiogram, electrocardiogram monitoring, laboratory tests (including blood biochemistry, blood routine, urine routine, coagulation function).
Measured: Day1 to Day 28
Secondary outcomes (18)
Single-Dose Pharmacokinetic (PK) Parameter (AUC0-∞)
Area under the concentration-time curve from time zero (pre-dose) extrapolation to infinite time.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (AUC0-last)
AUC from time zero (pre-dose) to the time of the last measured concentration.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Cmax)
Maximum observed plasma concentration.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Tmax)
Time to the maximum plasma concentration.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (T1/2)
Elimination half-life.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (CL/F)
Apparent total plasma clearance.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Kel)
Elimination rate constant.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (MRT)
Mean residence time.
Measured: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Vz/F)
Apparent volume of distribution.
Measured: Day 1
Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_max)
Maximum concentration during a dosing interva.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_min)
Minimum concentration during a dosing interval.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (AUCtau)
AUC over one dosing interval.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Tmax)
Time to the maximum plasma concentration.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (T1/2)
Elimination half-life.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (CL/F)
Apparent total plasma clearance.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (DF)
Degree of fluctuation.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_av)
Mean plasma concentration during a dosing interval.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Rac)
Accumulation factor.
Measured: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start22 Apr 2025
- Primary completion20 Nov 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASHStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cascade Pharmaceuticals, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Shuyang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485245
- Sponsor's protocol ID
- CS060304-FIH-CN-I-01
- Status last verified
- Mar 2026
- First submitted
- 26 Jun 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect of Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalations of CS060304 in Healthy and Elevated LDL-C Subjects
- ClinicalTrials.gov ID
- NCT06485245
- Acronym / sponsor ID
- CS060304-FIH-CN-I-01
- Conditions
- MASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cascade Pharmaceuticals, IncUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects.
Detailed description
A Phase I study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effects of Randomised, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalations of CS060304 in Healthy and Elevated LDL-C Subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: 0.2mg CS060304 | Experimental | Drug: CS060304Healthy subjects in a fasting state will receive a single dose of CS060304 0.2 mg or placebo. |
| Cohort A2: 1mg CS060304 | Experimental | Drug: CS060304Healthy subjects in a fasting state will receive a single dose of CS060304 1 mg or placebo. |
| Cohort A3: 4mg CS060304 | Experimental | Drug: CS060304Healthy subject in fasted state receive a single oral dose of CS060304 4 mg or placebo on day 1, followed by a 4 day washout period, subjects in fed state will receive the same single oral dose of CS060304 4mg or placebo on day 5. |
| Cohort A4: 10mg CS060304 | Experimental | Drug: CS060304Healthy subjects in a fasting state will receive a single dose of CS060304 10 mg or placebo. |
| Cohort A5: 20mg CS060304 | Experimental | Drug: CS060304Healthy subjects in a fasting state will receive a single dose of CS060304 20 mg or placebo. |
| Cohort A6: 40mg CS060304 | Experimental | Drug: CS060304Healthy subjects in a fasting state will receive a single dose of CS060304 40 mg or placebo. |
| Cohort B1: 2mg CS060304 | Experimental | Drug: CS060304Elevated LDL-C subjects will receive the CS060304 2 mg or placebo once daily for a consecutive 14 days. |
| Cohort B2: 5mg CS060304 | Experimental | Drug: CS060304Elevated LDL-C subjects will receive the CS060304 5 mg or placebo once daily for a consecutive 14 days. |
| Cohort B3: 10mg CS060304 | Experimental | Drug: CS060304Elevated LDL-C subjects will receive the CS060304 10 mg or placebo once daily for a consecutive 14 days. |
| Cohort B4: 20mg CS060304 | Experimental | Drug: CS060304Elevated LDL-C subjects will receive the CS060304 20 mg or placebo once daily for a consecutive 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- SAD
- Sign and date the ICF.
- Signing ICF age≥18 years≤55 years, male or female.
- Weight: Male≥50kg, female≥45kg BMI: 18~28kg/m².
- Female or male subjects must be eligible for contraception during the study and for three months after the last dose.
Key exclusion criteria (55 listed)
- SAD
- Special dietary requirements, not following a uniform diet.
- Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
- History of febrile illness or active infection within 7 days prior to first dose.
- Positive urine drug screens at screening or baseline.
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 |
|---|---|---|
| CS060304Also: PleacboTablets administered orally | Drug | Cohort A1: 0.2mg CS060304, Cohort A2: 1mg CS060304, Cohort A3: 4mg CS060304, Cohort A4: 10mg CS060304, Cohort A5: 20mg CS060304, Cohort A6: 40mg CS060304, Cohort B1: 2mg CS060304, Cohort B2: 5mg CS060304, Cohort B3: 10mg CS060304, Cohort B4: 20mg CS060304 |
Primary outcome
Safety and tolerability
Time frame: Day1 to Day 28
Physical examination, vital signs, including blood pressure, pulse, respiratory rate, and body temperature, 12 lead electrocardiogram, electrocardiogram monitoring, laboratory tests (including blood biochemistry, blood routine, urine routine, coagulation function).
18 secondary outcomes
Single-Dose Pharmacokinetic (PK) Parameter (AUC0-∞)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (AUC0-last)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Cmax)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Tmax)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (T1/2)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (CL/F)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Kel)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (MRT)
Time frame: Day 1
Single-Dose Pharmacokinetic (PK) Parameter (Vz/F)
Time frame: Day 1
Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_max)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_min)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (AUCtau)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Tmax)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (T1/2)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (CL/F)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (DF)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_av)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Multiple-Dose Pharmacokinetic (PK) Parameter (Rac)
Time frame: Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
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 13 Mar 2026.
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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.
Zhang Shuyang principal investigator
Peking Union Medical College 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 CS060304 in people with MASH, run by Cascade Pharmaceuticals, Inc 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 19 inclusion and 55 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. 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?
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?
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?
Safety and tolerability (time frame: Day1 to Day 28). 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 13 Mar 2026.