A Randomized, Double-blind, Placebo-controlled, Phase 1 Study Evaluating the Safety and Pharmacokinetics of Subcutaneous Administration of Single Ascending Doses of DR-01 in Healthy Volunteers

Dren Bio1 site in 1 country32 target enrollmentMarch 3, 2025

ConditionsHealthy Volunteer

InterventionsDR-01 Placebo

DrugsDR-01

Overview

Phase: Phase 1
Intervention: DR-01
Conditions: Healthy Volunteer
Sponsor: Dren Bio
Enrollment: 32
Locations: 1
Primary Endpoint: Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v5.0 after a single SC dose
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, and PD of SC administration of single ascending doses of DR-01 in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

March 3, 2025

End Date

August 27, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dren Bio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, in the opinion of the Investigator, as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range that is not specifically listed in the inclusion or exclusion criteria may be included if the Investigator (in consultation with the Medical Monitor) agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures, subject safety, or data interpretation.
•Between 18 and 65 years of age, inclusive, of any race or gender.
•Body weight at screening ≥ 40 kg and \< 120 kg, with body mass index between 18 and 35 kg/m
•Adequate abdominal adipose tissue for SC injection.
•Ability to understand and comply with protocol-required study procedures, including admission to the Clinical Research Unit the day prior to dosing with an overnight stay, and voluntarily sign a written informed consent document.
•Use of a highly effective contraceptive measure (\< 1% failure rate; see Section 13.1) for all males and all females of childbearing potential during study and 90 days postdose for males and 30 days postdose for females. Bilateral tubal ligation performed 6 months prior to screening is considered a highly effective contraceptive measure for female subjects and female partners of male subjects and does not require the use of additional contraception. Females of childbearing potential must have a confirmatory negative urine pregnancy test on Day -1/prior to dosing on Day
•Females who are not of childbearing potential (i.e., who are considered to be postmenopausal \[≥ 12 months of non-therapy amenorrhea\] or surgically sterile \[absence of ovaries and/or uterus or bilateral tubal ligation\]) are not required to have a pregnancy test or use contraception.

Exclusion Criteria

•History or presence of a disease or condition that, in the Investigator's opinion, constitutes a risk when taking study drug or interfering with study assessment or interpretation of the data.
•Medical history of severe allergic reaction, angioedema, anaphylaxis, clinically significant drug hypersensitivity reaction, or autoimmune or immunodeficiency disorder.
•History of malignant neoplasm within 5 years prior to screening, except for fully treated nonmetastatic basal or squamous cell cancers of the skin (within 3 years) that shows no evidence of recurrence.
•Any of the following types of infection within 28 days of screening or before randomization:
•Serious (requiring hospitalization, and/or IV antimicrobial treatment).
•Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
•Viral reactivation of CMV, EBV, VZV, or HSV type infection requiring systemic therapy in the last 2 years. Periodic HSV viral reactivation (e.g., cold sore) treated with a short course of systemic antiviral therapy within the last 2 years would not be exclusionary.
•Any of the following:
•Current infection with HBV (i.e., positive for HBsAg and/or polymerase chain reaction positive for HBV DNA).
•Current infection with HCV (i.e., positive for HCV RNA).