Health VolunteerPhase 1NCT05539651
A Single and Multiple Ascending Doses Study to Evaluate the Safety and Pharmacokinetics of RBD5044
A Phase 1 study testing RBD5044 in people with Health Volunteer, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, PK profiles and PD effect of single and multiple ascending doses of subcutaneously administered RBD5044 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- RBD5044
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Nov 2022to 30 Oct 2024
- 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
- A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
- Male and female subjects, aged 18 to 65 years (inclusive).
- Body mass index between 18 and 32 kg/m2, inclusive.
- Fasting TG ≥ 0.9 mmol/L (80 mg/dL) and ≤ 3.4 mmol/L (300 mg/dL) at screening.
- Fasting LDL-C < 4.9 mmol/L (<190 mg/dL) at screening.
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- Healthy as determined by pre-study medical history, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG).
- Satisfy one of the following:
- Females: must be non-pregnant and non-lactating; surgically sterile, post-menopausal, abstinent, or if engaged in sexual relations of child-bearing potential, the subject is using an acceptable contraceptive method (refer to Section 4.6.3) for four weeks before, during, and for at least 6 months after the last dose of study drug administration.
- Males: must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, the subject is utilizing an acceptable contraceptive method (refer to Section 4.6.3)) during and for at least 6 months after the last dose of study drug administration.
- Non-smokers and non-nicotine users for at least 90 days before screening
Who cannot join
- A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
- Any uncontrolled or serious disease, or any medical or surgical condition, may interfere with participation in the clinical study and/or put the subject at significant risk (according to the investigator's judgment) if he/she participates in the clinical study.
- History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease).
- Systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg after 10 minutes of supine rest, unless determined by the investigator to be not clinically relevant.
- Diagnosis of diabetes mellitus.
- Received any medication or nutraceutical to alter serum lipids within 30 days before screening.
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- Active serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention.
- Alanine aminotransferase (ALT) and/or total bilirubin are above the upper limit of normal reference range (ULN); no investigator discretion and repeat assessments are allowed.
- Aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) > 2 × ULN (no investigator discretion); or, if AST, ALP, or GGT > ULN, but ≤ 2 × ULN and considered clinically relevant by the investigator.
- Used prescription drugs within 14 days or 7 half-lives (whichever is longer) before the first dose of study drug.
- Used over-the-counter medication, excluding routine vitamins, within 7 days before the first dose of the study drug, unless determined by the investigator to be not clinically relevant, and unlikely to impact blood lipids level.
- Received an investigational product within 30 days or 7 half-lives (whichever is longer) before the first dose of the study drug or are in the follow-up of another clinical study. If subjects used advanced therapy (ASO/siRNA/gene therapy/cell therapy), it should be judged by the investigator.
- Hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), syphilis infection, or positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), HIV antibody (HIVAb), treponema pallidum antibody (TP-Ab) at screening.
- Clinically significant illness within 7 days before the first dose of the study drug.
- Consume more than 14 (female) or 21 (male) units of alcohol per week (unit: 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer) within the 12 months before screening or positive screen for alcohol abuse.
- History or clinical evidence of drug abuse within the 12 months before screening or positive screen for drug abuse. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a dose reduction will lead to withdrawal symptoms.
- Donated more than 500 mL of blood within 90 days before the first dose of the study drug.
- History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc).
- History of intolerance to subcutaneous (SC) injection or relevant abdominal scarring (surgical, burns, etc.).
- Any conditions which would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of Subcutaneously Administered RBD5044 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, PK profiles and PD effect of single and multiple ascending doses of subcutaneously administered RBD5044 in healthy subjects. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in healthy subjects. There are 6 cohorts in SAD phases, the dose levels are 5mg, 20mg, 60mg, 90mg, 120mg and 150mg. There are 3 cohorts in MAD phases, the dose levels are 60mg, 90mg and 120mg.The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information, including AEs, ECGs, vital signs, and clinical laboratory test results in each cohort.
- Conditions
- Health Volunteer
- Being tested
- RBD5044, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD5044Drug
Subcutaneously Administered RBD5044 in Healthy Subjects
PlaceboDrug
Subcutaneously Administered Placebo in Healthy Subjects
| Study group | Role | What they receive |
|---|---|---|
| RBD5044 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD5044 on Day 1. Receives: Drug: RBD5044 |
| RBD5044 MAD experimental group | Experimental | Subjects in MAD experimental groups will receive one subcutaneous injection of RBD5044 on Day 1 and another subcutaneous injection of RBD5044 on Day 29. Receives: Drug: RBD5044 |
| Placebo SAD group | Placebo comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1. Receives: Drug: Placebo |
| Placebo MAD group | Placebo comparator | Subjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 1 and another subcutaneous injection of placebo on Day 29. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
Measured: SAD: Up to 24 weeks; MAD: Up to 28 weeks
Secondary outcomes (11)
To characterize the pharmacokinetic parameter Cmax of RBD5044 in healthy subjects
Plasma Maximum concentration (Cmax)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter Tmax of RBD5044 in healthy subjects
Time to maximum concentration (Tmax)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter AUC0-inf of RBD5044 in healthy subjects
Area under the concentration-time curve from 0 to infinity (inf) (AUC0-inf)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter AUC0-t of RBD5044 in healthy subjects
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter t1/2 of RBD5044 in healthy subjects
Plasma Half-Life (t1/2)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter λz of RBD5044 in healthy subjects
Terminal rate constant (λz)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter MRT of RBD5044 in healthy subjects
mean residence time (MRT)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter CL/F of RBD5044 in healthy subjects
Oral clearance (CL/F)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter Vz/F of RBD5044 in healthy subjects
Volume of distribution in the terminal elimination period (Vz/F)
Measured: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To evaluate the pharmacodynamics (PD) effect of RBD5044 on serum levels of APOC3 in healthy subjects
by testing Concentrations of APOC3
Measured: SAD: Up to 24 weeks; MAD: Up to 28 weeks
To evaluate the PD effect of RBD5044 on serum levels of triglyceride (TG) in healthy subjects.
by testing Concentrations of TG
Measured: SAD: Up to 24 weeks; MAD: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start10 Nov 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteerStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539651
- Sponsor's protocol ID
- RBAP1101
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2022
- Last updated
- 4 Dec 2024
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of Subcutaneously Administered RBD5044 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05539651
- Acronym / sponsor ID
- RBAP1101
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 14 Sep 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.
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, PK profiles and PD effect of single and multiple ascending doses of subcutaneously administered RBD5044 in healthy subjects. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in healthy subjects. There are 6 cohorts in SAD phases, the dose levels are 5mg, 20mg, 60mg, 90mg, 120mg and 150mg. There are 3 cohorts in MAD phases, the dose levels are 60mg, 90mg and 120mg.The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information, including AEs, ECGs, vital signs, and clinical laboratory test results in each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RBD5044 SAD experimental group | Experimental | Drug: RBD5044Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD5044 on Day 1. |
| RBD5044 MAD experimental group | Experimental | Drug: RBD5044Subjects in MAD experimental groups will receive one subcutaneous injection of RBD5044 on Day 1 and another subcutaneous injection of RBD5044 on Day 29. |
| Placebo SAD group | Placebo comparator | Drug: PlaceboSubjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1. |
| Placebo MAD group | Placebo comparator | Drug: PlaceboSubjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 1 and another subcutaneous injection of placebo on Day 29. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
- Male and female subjects, aged 18 to 65 years (inclusive).
- Body mass index between 18 and 32 kg/m2, inclusive.
- Fasting TG ≥ 0.9 mmol/L (80 mg/dL) and ≤ 3.4 mmol/L (300 mg/dL) at screening.
Key exclusion criteria (20 listed)
- A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
- Any uncontrolled or serious disease, or any medical or surgical condition, may interfere with participation in the clinical study and/or put the subject at significant risk (according to the investigator's judgment) if he/she participates in the clinical study.
- History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease).
- Systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg after 10 minutes of supine rest, unless determined by the investigator to be not clinically relevant.
- Diagnosis of diabetes mellitus.
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 |
|---|---|---|
| RBD5044Subcutaneously Administered RBD5044 in Healthy Subjects | Drug | RBD5044 MAD experimental group, RBD5044 SAD experimental group |
| PlaceboSubcutaneously Administered Placebo in Healthy Subjects | Drug | Placebo MAD group, Placebo SAD group |
Primary outcome
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time frame: SAD: Up to 24 weeks; MAD: Up to 28 weeks
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
11 secondary outcomes
To characterize the pharmacokinetic parameter Cmax of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter Tmax of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter AUC0-inf of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter AUC0-t of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter t1/2 of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter λz of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter MRT of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter CL/F of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To characterize the pharmacokinetic parameter Vz/F of RBD5044 in healthy subjects
Time frame: SAD: within 60 minutes before dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after dosing; MAD: within 60 minutes before day 1 and day 29 dosing, and at 0.25, 0.5, 1, 2, 4, 6, 8,10,12, 24 and 48 hours after Day 1 and day 29 dosing
To evaluate the pharmacodynamics (PD) effect of RBD5044 on serum levels of APOC3 in healthy subjects
Time frame: SAD: Up to 24 weeks; MAD: Up to 28 weeks
To evaluate the PD effect of RBD5044 on serum levels of triglyceride (TG) in healthy subjects.
Time frame: SAD: Up to 24 weeks; MAD: Up to 28 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 4 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 RBD5044 in people with Health Volunteer, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in Australia.
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 11 inclusion and 20 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 4 Dec 2024. 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 Australia. 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 of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 (time frame: SAD: Up to 24 weeks; MAD: Up to 28 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 4 Dec 2024.