A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers

NCT06008652 | Completed Phase 1

• 1 other identifier: DR-0201-HV-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers.

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose

  Up to 57 days

Secondary Outcomes (4)

• PK after a single IV dose: area under the plasma concentration time curve [AUC0-t].

  Up to 57 days

• PK after a single IV dose: maximum observed plasma concentration [Cmax].

  Up to 57 days

• PK after a single IV dose: time of occurrence of Cmax (tmax),

  Up to 57 days

• PK after a single IV dose: estimated half-life

  Up to 57 days

Study Arms (2)

DR-0201

EXPERIMENTAL

Subjects in this arm will receive a single dose of DR-0201

Drug: DR-0201

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive a single dose of placebo

Drug: Placebo

Interventions

DR-0201 DRUG

DR-0201 is a bi-specific antibody

DR-0201

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
• Body weight at screening ≥ 40 kg and \< 120 kg, with body mass index between 18 and 30 kg/m2.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, including the protocol-mandate hospitalization.
• 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 post dose for males and 30 days post dose for females. Females of childbearing potential need to have a confirmatory urine pregnancy test on Day -1. Females who are not of childbearing potential (i.e., who are considered to be post-menopausal \[≥ 12 months of non-therapy amenorrhea\] or surgically sterile \[absence
• 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 (e.g., autoimmune disease). Subjects post cholecystectomy are acceptable. Subjects with resolved childhood asthma not requiring prescription medicine are acceptable. Subjects with Gilbert's disease are acceptable if total bilirubin ≤3× ULN.
• Medical history of severe allergic reaction, angioedema, anaphylaxis, clinically significant drug hypersensitivity reaction, or autoimmune or immunodeficiency disorder.
• Active infection or a history of serious infections as follows:
• Use of antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) for an infection within 30 days before first dose. Topical treatments may be allowed at the Medical Monitor's discretion.
• History of opportunistic infections in the last 2 years.
• Recurrent or chronic infection, or other active infection, that in the opinion of the Investigator might cause this study to be detrimental to the subject.
• Symptomatic herpes zoster within 3 months prior to screening.
• History of tuberculosis (active or latent) irrespective of treatment status.
• Any history of viral hepatitis: hepatitis B virus, hepatitis C virus (HCV), hepatitis E virus.
• HCV is acceptable if HCV RNA is undetectable for at least 3 months post completion of direct-acting antiviral therapy.
• Any known history of John Cunningham virus (JCV) infection or progressive multifocal leukoencephalopathy (PML).

Sponsors & Collaborators

• Dren Bio: lead
• Novotech: collaborator

Study Sites (1)

Dren Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• Matthias Will, MD

  Dren Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 23, 2023
• Study Start: November 26, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)