Normal Healthy VolunteersPhase 1NCT02802631
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults
A Phase 1 study testing Minocin (minocycline) for Injection in people with Normal Healthy Volunteers, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 1 site in Netherlands.
Trial summary
This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Volunteers
- What is being tested?
- Minocin (minocycline) for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Apr 2017to 8 Feb 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A signed informed consent form, the ability to understand the study conduct and tasks that were required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol, whether in the research unit or after discharge, for the duration of the study
- Male or female between 18 and 50 years of age inclusive
- Participant had a body mass index ≥18 kilograms/square meter (kg/m^2) and ≤30 kg/m^2.
- Participant was non-smoker or smokes up to 5 cigarettes per day (or equivalent).
- Participant was in good health based on medical history and physical examination findings and had no clinically meaningful safety laboratory abnormalities (hematology, blood chemistry, and urinalysis) or 12-lead electrocardiogram results, as assessed by the Principal Investigator.
- Vital signs (blood pressure, pulse, respiratory rate and temperature) measured at screening/baseline must have been within the following ranges: systolic blood pressure ≥90 to ≤150 millimeters of mercury (mm Hg), diastolic blood pressure ≥45 to ≤90 mm Hg; heart rate ≥45 to ≤90 beats per minute (taken after resting in a supine position for at least 5 minutes).
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- Expectation that intravenous access would be sufficient to allow for ease of study drug infusion, and for all protocol-required blood sampling to take place
- Participant committed to remaining admitted in the research unit for the course of the study.
- Female participant was surgically sterile, postmenopausal: period of amenorrhea for at least 2 years, or if of childbearing potential, agreed to abstinence or to use at least 2 acceptable methods of birth control (for example prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods) or male partner sterilization alone, between the first dose (Day 1) and for 90 days after the completion of the study.
Who cannot join
- Had any condition, including findings in the medical history or in pre-study assessments that constituted a risk or a contraindication for the participation in the study or completing the study
- Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening and Day -1 Visits
- Had a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse was defined as regularly consuming >3 units/day (21 units per week for men), >2 units/day (14 units/week) for women. A unit was defined as a can of 4% beer (330 mL), approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), a glass of wine (100 mL).
- Participant showed positive hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus I/II antibodies and antigen tests.
- Participant had active or ongoing candida infection.
- Blood or plasma donation within past 2 months
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- Females who were pregnant or nursing or who had a positive pregnancy test result at the Screening Visit or Day -1 prior to dosing
- Males who were unwilling to practice abstinence or use an acceptable method of birth control during the entire study period and for 90 days after the completion of the study (that is condom with spermicide, where locally available)
- Presence of known raised intracranial pressure
- Use of retinoids (for example, isotretinoin)
- History of significant hypersensitivity or allergic reaction to any of the tetracycline class of antibiotics or the components of those antibiotics
- Receipt of any investigational medication or investigational device during the last 30 days prior to randomization
- Treatment with any prescription, vitamins or over-the-counter drugs, within 2 weeks or five half-lives, whichever was longer, or herbal nutritional supplements within 2 weeks of screening, with the exception of acetaminophen/paracetamol for minor headache. Participants were not allowed to receive medications for the duration of the study (except the abovementioned acetaminophen/paracetamol). Birth control or other hormone replacement were also permitted as long as it had been taken at a stable dose for at least 3 months before the Screening Visit and remained stable for the duration of the study.
- A corrected QT interval by Fridericia >480 milliseconds
- Calculated creatinine clearance less than 50 mL/minute (Cockcroft-Gault method) at screening or check-in (Day -1)
- Unable or unwilling, in the judgment of the Investigator, to comply with the protocol
- An employee of the Investigator, the study center, the sponsor or The Medicines Company with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, or a family member of the employee or the Investigator
- Prior enrollment in any minocycline study including prior cohorts in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (Minocycline) for Injection in Healthy Adult Subjects
This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adult participants.
Read the detailed description
The purpose of this study was to collect safety, tolerability, and pharmacokinetic (PK) data on ascending dose regimens of Minocin (minocycline) for Injection. The safety, tolerability, and PK data was to support the compound as a potential clinical candidate in Europe and allow recommendations of dose levels to be used in future Phase 2/3 studies.
- Conditions
- Normal Healthy Volunteers
- Being tested
- Minocin (minocycline) for Injection, Placebo
- Keywords
- Bacterial infections
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocin (minocycline) for InjectionDrug
Also called Minocin, Minocycline
Intravenous formulation of minocycline, a derivative of tetracycline
PlaceboOther
Placebo - Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Minocin (minocycline) for Injection | Experimental | Minocin (minocycline) for Injection was supplied as a sterile lyophilized powder in single-use 10-milliliter (mL) glass vials. Each vial contained 108 milligrams (mg) of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort received one of the following dosages of Minocin (minocycline) for Injection: 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, or 600 mg. Within each cohort, participants received a single dose on Day 1, followed by 7 days of multiple doses (Days 4 to 10, given every 12 hours), followed by a single dose on Day 11. Receives: Drug: Minocin (minocycline) for Injection |
| 0.9% Sodium Chloride Injection USP | Placebo comparator | Placebo was in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection United States Pharmacopeia [USP]). Dosing was on the same schedule as participants randomized to Minocin (minocycline) for Injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants Experiencing Treatment-emergent Adverse Events
Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of participants with adverse events.
Measured: Day 1 through Day 17
Secondary outcomes (12)
Assessment of Area Under The Concentration-time Curve From Zero Hours To The Last Measured Concentration (AUC0-t) After A Single Dose Of Minocin On Day 1
Assessment of AUC0-t by cohort after a single intravenous dose of Minocin (minocycline) for Injection on Day 1 is reported as mg times hour/liter (mg*h/L).
Measured: Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of AUC0-t By Cohort After A Single Dose Of Minocin On Day 4
Assessment of AUC0-t by cohort after a single dose of Minocin (minocycline) for Injection using plasma from serial blood samples on Day 4 is reported.
Measured: Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing)
Assessment Of AUC0-t By Cohort After Multiple Doses Of Minocin On Day 11
Assessment of AUC0-t by cohort after 7 days of multiple doses of Minocin (minocycline) for Injection using plasma from serial blood samples on Day 11 is reported.
Measured: Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of Maximum Plasma Concentration (Cmax) By Cohort For A Single Dose Of Minocin On Day 1
Assessment of Cmax by cohort for a single intravenous dose of Minocin (minocycline) for Injection using serial blood samples on Day 1 is reported.
Measured: Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment of Cmax by Cohort for a Single Dose of Minocin on Day 4
Assessment of Cmax by cohort for a single intravenous dose of Minocin (minocycline) for Injection using serial blood samples on Day 4 is reported.
Measured: Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing)
Assessment Of Cmax By Cohort For Multiple Doses Of Minocin On Day 11
Assessment of Cmax by cohort after 7 days of twice daily dosing of Minocin (minocycline) for Injection using serial blood samples on Day 11 is reported.
Measured: Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of Apparent Terminal Elimination Half-life (T1/2) By Cohort For A Single Dose Of Minocin Using Plasma From Serial Blood Samples On Day 1
Assessment of T1/2, defined by T1/2 = natural log of 2 divided by elimination constant (Kel) (T1/2), by cohort after a single intravenous dose of Minocin (minocycline) for Injection on Day 1 is reported.
Measured: Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of T1/2 By Cohort After Multiple Doses Of Minocin Using Plasma From Serial Blood Samples On Day 11
Assessment of T1/2, defined by T1/2 = natural log of 2 divided by Kel (T1/2), by cohort after 7 days of twice daily dosing of intravenous doses of Minocin (minocycline) for Injection on Day 11 is reported.
Measured: Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of Amount Of Drug Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1
Assessment of amount of drug excreted in urine after a single intravenous dose of Minocin (minocycline) for Injection using serial urine samples on Day 1 is reported.
Measured: Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing
Assessment Of Amount Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11
Assessment of amount of drug excreted in urine after 7 days of twice daily intravenous doses of Minocin (minocycline) for Injection using serial urine samples on Day 11 is reported.
Measured: Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing
Assessment Of Percent of Dose Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1
Assessment of percent of dose excreted in urine after a single intravenous dose of Minocin (minocycline) for Injection using serial urine samples on Day 1 is reported.
Measured: Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing)
Assessment Of Percentage Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11
Assessment of percentage of drug excreted in urine after 7 days of twice daily intravenous doses of Minocin (minocycline) for Injection using serial urine samples on Day 11 is reported.
Measured: Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start20 Apr 2017
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Normal Healthy VolunteersStudies 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
- Model Description: Cohorts 1 and 2 were run concurrently as they were using the approved doses of intravenous minocycline in the United States. Cohorts 3, 4, 5 and 6 were run sequentially and only after review of data from the preceding cohorts by the data monitoring committee.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Köln, Innovative Medicines Initiative
- Responsible party
- Sponsor
- Investigators
- Dr. Naguib Muhsen, MD, Principal investigator, QPS Holdings LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802631
- Sponsor's protocol ID
- MDCO-MIN-16-02
- Other IDs
- 701 (IMI WP8A ID #)
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2016
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (Minocycline) for Injection in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02802631
- Acronym / sponsor ID
- MDCO-MIN-16-02
- Conditions
- Normal Healthy Volunteers
- Keywords
- Bacterial infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Industry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Köln, Innovative Medicines Initiative
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adult participants.
Detailed description
The purpose of this study was to collect safety, tolerability, and pharmacokinetic (PK) data on ascending dose regimens of Minocin (minocycline) for Injection. The safety, tolerability, and PK data was to support the compound as a potential clinical candidate in Europe and allow recommendations of dose levels to be used in future Phase 2/3 studies.
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
- Model Description: Cohorts 1 and 2 were run concurrently as they were using the approved doses of intravenous minocycline in the United States. Cohorts 3, 4, 5 and 6 were run sequentially and only after review of data from the preceding cohorts by the data monitoring committee.
| Arm | Type | Receives |
|---|---|---|
| Minocin (minocycline) for Injection | Experimental | Drug: Minocin (minocycline) for InjectionMinocin (minocycline) for Injection was supplied as a sterile lyophilized powder in single-use 10-milliliter (mL) glass vials. Each vial contained 108 milligrams (mg) of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort received one of the following dosages of Minocin (minocycline) for Injection: 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, or 600 mg. Within each cohort, participants received a single dose on Day 1, followed by 7 days of multiple doses (Days 4 to 10, given every 12 hours), followed by a single dose on Day 11. |
| 0.9% Sodium Chloride Injection USP | Placebo comparator | Other: PlaceboPlacebo was in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection United States Pharmacopeia [USP]). Dosing was on the same schedule as participants randomized to Minocin (minocycline) for Injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- A signed informed consent form, the ability to understand the study conduct and tasks that were required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol, whether in the research unit or after discharge, for the duration of the study
- Male or female between 18 and 50 years of age inclusive
- Participant had a body mass index ≥18 kilograms/square meter (kg/m^2) and ≤30 kg/m^2.
- Participant was non-smoker or smokes up to 5 cigarettes per day (or equivalent).
- Participant was in good health based on medical history and physical examination findings and had no clinically meaningful safety laboratory abnormalities (hematology, blood chemistry, and urinalysis) or 12-lead electrocardiogram results, as assessed by the Principal Investigator.
Key exclusion criteria (18 listed)
- Had any condition, including findings in the medical history or in pre-study assessments that constituted a risk or a contraindication for the participation in the study or completing the study
- Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening and Day -1 Visits
- Had a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse was defined as regularly consuming >3 units/day (21 units per week for men), >2 units/day (14 units/week) for women. A unit was defined as a can of 4% beer (330 mL), approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), a glass of wine (100 mL).
- Participant showed positive hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus I/II antibodies and antigen tests.
- Participant had active or ongoing candida infection.
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 |
|---|---|---|
| Minocin (minocycline) for InjectionAlso: Minocin, MinocyclineIntravenous formulation of minocycline, a derivative of tetracycline | Drug | Minocin (minocycline) for Injection |
| PlaceboPlacebo - Normal Saline | Other | 0.9% Sodium Chloride Injection USP |
Primary outcome
Number Of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 17
Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of participants with adverse events.
12 secondary outcomes
Assessment of Area Under The Concentration-time Curve From Zero Hours To The Last Measured Concentration (AUC0-t) After A Single Dose Of Minocin On Day 1
Time frame: Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of AUC0-t By Cohort After A Single Dose Of Minocin On Day 4
Time frame: Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing)
Assessment Of AUC0-t By Cohort After Multiple Doses Of Minocin On Day 11
Time frame: Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of Maximum Plasma Concentration (Cmax) By Cohort For A Single Dose Of Minocin On Day 1
Time frame: Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment of Cmax by Cohort for a Single Dose of Minocin on Day 4
Time frame: Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing)
Assessment Of Cmax By Cohort For Multiple Doses Of Minocin On Day 11
Time frame: Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of Apparent Terminal Elimination Half-life (T1/2) By Cohort For A Single Dose Of Minocin Using Plasma From Serial Blood Samples On Day 1
Time frame: Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of T1/2 By Cohort After Multiple Doses Of Minocin Using Plasma From Serial Blood Samples On Day 11
Time frame: Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of Amount Of Drug Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1
Time frame: Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing
Assessment Of Amount Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11
Time frame: Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing
Assessment Of Percent of Dose Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1
Time frame: Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing)
Assessment Of Percentage Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11
Time frame: Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dr. Naguib Muhsen, MD principal investigator
QPS Holdings LLC
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 Minocin (minocycline) for Injection in people with Normal Healthy Volunteers, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 1 site in Netherlands.
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 9 inclusion and 18 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 15 Dec 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Experiencing Treatment-emergent Adverse Events (time frame: Day 1 through Day 17). 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 15 Dec 2023.