OverweightPhase 1NCT05096598
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
A Phase 1 study testing ZP8396 in people with Overweight and Healthy Volunteers, run by Zealand Pharma at 1 site in Germany.
Trial summary
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy Volunteers
- What is being tested?
- ZP8396
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2021to 12 Jan 2023
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject
- Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
- Body weight of at least 70.0 kg
- Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent
- Further inclusion criteria apply
Who cannot join
- History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
- Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg
- Symptoms of arterial hypotension
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
Germany1 site
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
About this study
Official title: A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).
Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.
- Conditions
- Overweight, Healthy Volunteers
- Being tested
- ZP8396, Placebo (ZP8396)
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP8396Drug
Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort.
Placebo (ZP8396)Drug
Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm).
| Study group | Role | What they receive |
|---|---|---|
| ZP8396 | Experimental | Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment. Receives: Drug: ZP8396 |
| Placebo (ZP8396) | Placebo comparator | In each of the 10 single dose cohorts, 2 subjects will receive placebo. Receives: Drug: Placebo (ZP8396) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Measured: From dosing (Day 1) to end of trial (Day 50)
Secondary outcomes (28)
Pharmacokinetics (PK) of ZP8396 (AUCτ)
Area under the plasma concentration-time curve over a dosing interval
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (AUCinf)
Area under the plasma concentration-time curve from time zero to infinity
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (AUClast)
Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (Cmax)
Maximum (peak) plasma drug concentration
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (tmax)
Time to reach maximum (peak) plasma concentration
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (λz)
Elimination rate constant
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (t½)
Elimination half-life
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (Vz/f)
Apparent volume of distribution during terminal phase
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (Vz)
Volume of distribution during the terminal phase (i.v. only)
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (CL/f)
Apparent total clearance of the drug from plasma
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (CL)
Total body clearance of the drug (i.v. only)
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (MRT)
Mean residence time
Measured: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)
Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)
Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)
Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)
Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])
Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])
Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)
Area under the Plasma Glucose (PG) concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)
Area under the Plasma Glucose (PG) concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)
Maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)
Time to maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)
Area under the insulin concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)
Area under the insulin concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)
Maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)
Time to maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)
Area under the glucagon concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)
Area under the glucagon concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Measured: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start19 Oct 2021
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zealand Pharma A/S, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096598
- Sponsor's protocol ID
- ZP8396-21037
- Other IDs
- 2021-001712-28, U1111-1267-1489
- Status last verified
- Jan 2023
- First submitted
- 14 Oct 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
- ClinicalTrials.gov ID
- NCT05096598
- Acronym / sponsor ID
- ZP8396-21037
- Conditions
- Overweight, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 27 Oct 2021 (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 research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).
Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.
| Arm | Type | Receives |
|---|---|---|
| ZP8396 | Experimental | Drug: ZP8396Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment. |
| Placebo (ZP8396) | Placebo comparator | Drug: Placebo (ZP8396)In each of the 10 single dose cohorts, 2 subjects will receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subject
- Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
- Body weight of at least 70.0 kg
- Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent
- Further inclusion criteria apply
Key exclusion criteria (4 listed)
- History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
- Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg
- Symptoms of arterial hypotension
- Further exclusion criteria apply
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 |
|---|---|---|
| ZP8396Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort. | Drug | ZP8396 |
| Placebo (ZP8396)Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). | Drug | Placebo (ZP8396) |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From dosing (Day 1) to end of trial (Day 50)
28 secondary outcomes
Pharmacokinetics (PK) of ZP8396 (AUCτ)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (AUCinf)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (AUClast)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (Cmax)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (tmax)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (λz)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (t½)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (Vz/f)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (Vz)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (CL/f)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (CL)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacokinetics (PK) of ZP8396 (MRT)
Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
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 17 Jan 2023.
- 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. This study is not recruiting at the moment.
Zealand Pharma A/S study director
Zealand Pharma A/S
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 ZP8396 in people with Overweight and Healthy Volunteers, run by Zealand Pharma at 1 site in Germany.
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 4 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 17 Jan 2023. 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 Germany. 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?
Incidence of treatment emergent adverse events (TEAEs) (time frame: From dosing (Day 1) to end of trial (Day 50)). 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 17 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.