A Study of Subcutaneous DR-01 in Healthy Volunteers

NCT06766864 | Completed Phase 1

• 1 other identifier: DR-01-HV-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v5.0 after a single SC dose

  Up to 57 days

Study Arms (5)

DL1 of DR-01

EXPERIMENTAL

Subjects in this arm will receive a single dose of dose level 1 of DR-01

Drug: DR-01

DL2 of DR-01

EXPERIMENTAL

Subjects in this arm will receive a single dose of dose level 2 of DR-01

Drug: DR-01

DL3 of DR-01

EXPERIMENTAL

Subjects in this arm will receive a single dose of dose level 3 of DR-01

Drug: DR-01

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive a single dose of placebo

Other: Placebo

DL4 of DR-01

EXPERIMENTAL

Subjects in this arm will receive a single dose of dose level 4 of DR-01

Drug: DR-01

Interventions

DR-01 DRUG

DR-01 is a monoclonal antibody

DL1 of DR-01; DL2 of DR-01; DL3 of DR-01; DL4 of DR-01

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may not qualify if:

• 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/m2.
• 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 1. 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.
• 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).
• Any of the following:
• HIV.
• 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).

Sponsors & Collaborators

• Dren Bio: lead

Study Sites (1)

Dren Investigational Site

Auckland, 1010, New Zealand

Location

Study Officials

• Michael Rothenberg, MD, PhD

  Dren Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: March 3, 2025
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)