Healthy VolunteerPhase 1NCT04898907
Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
A Phase 1 study testing ANG-3777 (Therapeutic Dose), ANG-3777 (Supra-therapeutic Dose) and Moxifloxacin Hydrochloride in people with Healthy Volunteer, run by Angion Biomedica Corp at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ANG-3777 (Therapeutic Dose), ANG-3777 (Supra-therapeutic Dose) and Moxifloxacin Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Sep 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight ≥50 kg and ≤100 kg at screening and admission
- Must be willing and able to comply with all study requirements
- Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures
- Must agree to use an adequate method of contraception
Who cannot join
- Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days.
- Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee
- Evidence of current SARS-CoV-2 infection
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
- A confirmed positive alcohol urine test at screening or admission
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- Current smokers and those who have smoked within the last 12 months or current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- A confirmed positive urine cotinine test at screening or admission.
- Positive drugs of abuse test result
Trial locations and contacts
1 site in 1 country.
United States1 site
Quotient Sciences
Miami, Florida, 33126
Jeffrey Levy, MD, PhD, 305-644-9903 ext. 166, jeffery.levy@quotientsciences.com
About this study
Official title: A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects
The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.
- Conditions
- Healthy Volunteer
- Being tested
- ANG-3777 (Therapeutic Dose), ANG-3777 (Supra-therapeutic Dose), Placebo, Moxifloxacin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG-3777 (Therapeutic Dose)Drug
Also called Hepatocyte growth factor mimetic
Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
ANG-3777 (Supra-therapeutic Dose)Drug
Also called Hepatocyte growth factor mimetic
Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
PlaceboDrug
Also called Normal Saline
Arms assigned to this intervention will receive normal saline, IV, Fasted
Moxifloxacin HydrochlorideDrug
Arms assigned to this intervention will receive 400 mg, Oral, Fasted
| Study group | Role | What they receive |
|---|---|---|
| ANG-3777 (Therapeutic Dose) | Experimental | Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. Receives: Drug: ANG-3777 (Therapeutic Dose) |
| Normal Saline | Placebo comparator | The placebo will be administered as a single dose on separate occasions intravenously as 30-minute infusions on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. Receives: Drug: Placebo |
| Moxifloxacin Hydrochloride | Active comparator | The comparator will be administered as a single dose oral Moxifloxacin Hydrochloride tablet (open-label), with a total of 240 mL of water. There will be a minimum washout of 3 days between each study drug administration. Receives: Drug: Moxifloxacin Hydrochloride |
| ANG-3777 (Supra-therapeutic Dose) | Experimental | Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. Receives: Drug: ANG-3777 (Supra-therapeutic Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo
Measured: Day 1, Day 5, Day 9 and Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study startJun 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Jeffrey Levy, MD, PhD, Principal investigator, Quotient Sciences - Miami, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898907
- Sponsor's protocol ID
- ANG3777-HV5-104
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 1 Jun 2021
- 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 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04898907
- Acronym / sponsor ID
- ANG3777-HV5-104
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 May 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 purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ANG-3777 (Therapeutic Dose) | Experimental | Drug: ANG-3777 (Therapeutic Dose)Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. |
| Normal Saline | Placebo comparator | Drug: PlaceboThe placebo will be administered as a single dose on separate occasions intravenously as 30-minute infusions on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. |
| Moxifloxacin Hydrochloride | Active comparator | Drug: Moxifloxacin HydrochlorideThe comparator will be administered as a single dose oral Moxifloxacin Hydrochloride tablet (open-label), with a total of 240 mL of water. There will be a minimum washout of 3 days between each study drug administration. |
| ANG-3777 (Supra-therapeutic Dose) | Experimental | Drug: ANG-3777 (Supra-therapeutic Dose)Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males or non-pregnant, non-lactating healthy females
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight ≥50 kg and ≤100 kg at screening and admission
- Must be willing and able to comply with all study requirements
Key exclusion criteria (9 listed)
- Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days.
- Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee
- Evidence of current SARS-CoV-2 infection
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
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 |
|---|---|---|
| ANG-3777 (Therapeutic Dose)Also: Hepatocyte growth factor mimeticArms assigned to this intervention will receive 2 mg/kg, IV, Fasted | Drug | ANG-3777 (Therapeutic Dose) |
| ANG-3777 (Supra-therapeutic Dose)Also: Hepatocyte growth factor mimeticArms assigned to this intervention will receive 6 mg/kg, IV, Fasted | Drug | ANG-3777 (Supra-therapeutic Dose) |
| PlaceboAlso: Normal SalineArms assigned to this intervention will receive normal saline, IV, Fasted | Drug | Normal Saline |
| Moxifloxacin HydrochlorideArms assigned to this intervention will receive 400 mg, Oral, Fasted | Drug | Moxifloxacin Hydrochloride |
Primary outcome
Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo
Time frame: Day 1, Day 5, Day 9 and Day 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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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.
Jeffrey Levy, MD, PhD principal investigator
Quotient Sciences - Miami, Inc.
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 ANG-3777 (Therapeutic Dose), ANG-3777 (Supra-therapeutic Dose) and Moxifloxacin Hydrochloride in people with Healthy Volunteer, run by Angion Biomedica Corp at 1 site in United States.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Jun 2021. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal Swiszcz (857-378-4175, cswiszcz@angion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo (time frame: Day 1, Day 5, Day 9 and Day 13). 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 1 Jun 2021.