A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants

NCT05105607 | Completed Phase 1 FDA Drug

• 1 other identifier: D-4517-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Keywords

D-4517.2; Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Day 1 up to Day 15

Secondary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of D-4517.2

  Day 1 up to Day 3

• Time to Maximum Plasma Concentration (tmax) of D-4517.2

  Day 1 up to Day 3

• Apparent Terminal Rate Constant (kel) of D-4517.2

  Day 1 up to Day 3

• Apparent Elimination Half-life (t1/2) of D-4517.2

  Day 1 up to Day 3

• Area Under the Concentration-time Curve Based On the Last Measurable Concentration (AUC0-t)

  Day 1 up to Day 3

Study Arms (4)

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.

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.

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.

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.

Drug: D-4517.2

Interventions

D-4517.2 DRUG

Subcutaneous (SC) injection

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening;
• 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.

Sponsors & Collaborators

• Ashvattha Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network (Brisbane)

Brisbane, Queensland, 4006, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 3, 2021
• Study Start: January 11, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)