Neovascular Age-related Macular DegenerationPhase 1NCT05105607
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants
A Phase 1 study testing D-4517.2 in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Ashvattha Therapeutics, Inc. at 1 site in Australia.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of D-4517.2 after single subcutaneous (SC) doses in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- D-4517.2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jan 2022to 31 Aug 2022
- 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
- Is a healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit;
- Has the ability to understand and sign the written informed consent form (ICF) and local medical privacy authorization forms, which must be obtained prior to any study related procedures being completed;
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive, with body weight ≤ 100 kg;
- Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator;
- Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges;
- Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants must use a medically accepted contraceptive regimen (including hormonal contraceptives) during their participation in the study and for 30 days after the last administration of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
Show all 19Show fewer
- Acceptable methods of contraception for male participants enrolled in the study include the following:
- Condoms or surgical sterilization of participant at least 26 weeks before the Screening Visit (vasectomy);
- Acceptable methods of contraception for female participants enrolled in the study include the following:
- Surgical sterilization of participant at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, oophorectomy, or salpingectomy);
- Intrauterine device for at least 4 weeks before the Screening Visit; or
- Hormonal contraception (oral, implant, injection, ring, or patch) for at least 4 weeks before the Screening Visit;
- If male, participants must agree to abstain from sperm donation through 90 days after administration of the last dose of study drug;
- Female participants may not be pregnant, lactating, or breastfeeding;
- Female participants of childbearing potential must have negative result for pregnancy test at screening and Check-in;
- Participants must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVab), and human immunodeficiency virus (HIV) antibody at screening;
- Participants must have an estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73m^2 at screening;
- Participants must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and Check-in; and
- Participants must be willing and able to abide by all study requirements and restrictions.
Who cannot join
- Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the participant at an unacceptable risk as a participant in this study;
- Evidence of systemic inflammation as measured by C-reactive protein above the upper limit of normal as measured by local lab;
- History of malignancy (other than successfully treated basal cell or squamous cell skin cancer);
- History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant;
- Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) above the upper limit of normal at screening and/or Check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator;
- Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening;
Show all 16Show fewer
- History of alcoholism or drug abuse within 2 years prior to screening;
- Has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study;
- Has had any immunizations (live vaccines) in the 4 weeks prior to screening; COVID-19 vaccination within 7 days of Day 1;
- Has used medications that affect GI motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day 1;
- Has used any prescription or over-the-counter medication (with exception of acetaminophen), vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to Day 1;
- Has used any other study drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Day 1;
- Has lost or donated >450 mL of whole blood or blood products within 30 days prior to screening;
- Investigator has reason to believe that the participant may be unable to fulfill the protocol visit schedule or requirements;
- Has any finding that, in the view of the Investigator or Medical Monitor, would compromise the participant's safety requirements; or
- Is employed by the Sponsor, the Contract Research Organization (CRO), or the study site (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, CRO, or study site employee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 (Hydroxyl Dendrimer VEGFR Tyrosine Kinase Inhibitor) After Subcutaneous Administration in Healthy Volunteers
The primary objective of this study is to evaluate the safety and tolerability of D-4517.2 after single subcutaneous (SC) doses in healthy participants.
- Being tested
- D-4517.2
- Keywords
- D-4517.2, Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-4517.2Drug
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 0.25 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 0.25 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the safety review committee (SRC) will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. Receives: Drug: D-4517.2 |
| Cohort 2: 0.5 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 0.5 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. Receives: Drug: D-4517.2 |
| Cohort 3: 1.0 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 1.0 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. Receives: Drug: D-4517.2 |
| Cohort 4: 2.0 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 2.0 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. Receives: Drug: D-4517.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: Day 1 up to Day 15
Secondary outcomes (7)
Maximum Plasma Concentration (Cmax) of D-4517.2
Measured: Day 1 up to Day 3
Time to Maximum Plasma Concentration (tmax) of D-4517.2
Measured: Day 1 up to Day 3
Apparent Terminal Rate Constant (kel) of D-4517.2
Measured: Day 1 up to Day 3
Apparent Elimination Half-life (t1/2) of D-4517.2
Measured: Day 1 up to Day 3
Area Under the Concentration-time Curve Based On the Last Measurable Concentration (AUC0-t)
Measured: Day 1 up to Day 3
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf)
Measured: Day 1 up to Day 3
Clearance (CL) of D-4517.2
Measured: Day 1 up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start11 Jan 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashvattha Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105607
- Sponsor's protocol ID
- D-4517-001
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 (Hydroxyl Dendrimer VEGFR Tyrosine Kinase Inhibitor) After Subcutaneous Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05105607
- Acronym / sponsor ID
- D-4517-001
- Keywords
- D-4517.2, Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ashvattha Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 3 Nov 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 primary objective of this study is to evaluate the safety and tolerability of D-4517.2 after single subcutaneous (SC) doses in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 0.25 mg/kg D-4517.2 | Experimental | Drug: D-4517.2Participants will be administered a single dose of 0.25 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the safety review committee (SRC) will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. |
| Cohort 2: 0.5 mg/kg D-4517.2 | Experimental | Drug: D-4517.2Participants will be administered a single dose of 0.5 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. |
| Cohort 3: 1.0 mg/kg D-4517.2 | Experimental | Drug: D-4517.2Participants will be administered a single dose of 1.0 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. |
| Cohort 4: 2.0 mg/kg D-4517.2 | Experimental | Drug: D-4517.2Participants will be administered a single dose of 2.0 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Is a healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit;
- Has the ability to understand and sign the written informed consent form (ICF) and local medical privacy authorization forms, which must be obtained prior to any study related procedures being completed;
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive, with body weight ≤ 100 kg;
- Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator;
- Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges;
Key exclusion criteria (16 listed)
- Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the participant at an unacceptable risk as a participant in this study;
- Evidence of systemic inflammation as measured by C-reactive protein above the upper limit of normal as measured by local lab;
- History of malignancy (other than successfully treated basal cell or squamous cell skin cancer);
- History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant;
- Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) above the upper limit of normal at screening and/or Check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator;
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 |
|---|---|---|
| D-4517.2Subcutaneous (SC) injection | Drug | Cohort 1: 0.25 mg/kg D-4517.2, Cohort 2: 0.5 mg/kg D-4517.2, Cohort 3: 1.0 mg/kg D-4517.2, Cohort 4: 2.0 mg/kg D-4517.2 |
Primary outcome
Number of Participants With Adverse Events
Time frame: Day 1 up to Day 15
7 secondary outcomes
Maximum Plasma Concentration (Cmax) of D-4517.2
Time frame: Day 1 up to Day 3
Time to Maximum Plasma Concentration (tmax) of D-4517.2
Time frame: Day 1 up to Day 3
Apparent Terminal Rate Constant (kel) of D-4517.2
Time frame: Day 1 up to Day 3
Apparent Elimination Half-life (t1/2) of D-4517.2
Time frame: Day 1 up to Day 3
Area Under the Concentration-time Curve Based On the Last Measurable Concentration (AUC0-t)
Time frame: Day 1 up to Day 3
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf)
Time frame: Day 1 up to Day 3
Clearance (CL) of D-4517.2
Time frame: Day 1 up to Day 3
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 21 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Neovascular Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
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 D-4517.2 in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Ashvattha Therapeutics, Inc. 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 19 inclusion and 16 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 21 Sep 2022. 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. 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 Adverse Events (time frame: Day 1 up to Day 15). 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 21 Sep 2022.