Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

NCT05921591 | Completed Phase 1 FDA Drug

• 1 other identifier: RVLO 111-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

  Number of subjects experiencing TEAE and number of TEAE will be summarised by treatment

  28 days

Secondary Outcomes (1)

• PK parameters of IRL201104 concentration in plasma

  28 days

Other Outcomes (1)

• Incidence of treatment-emergent anti-drug antibody (ADA) responses

  28 days

Study Arms (3)

Dose A IRL201104

EXPERIMENTAL

IRL201104 or placebo IV on days 1 and 7

Drug: IRL201104; Drug: Placebo

Dose B IRL201104

EXPERIMENTAL

IRL201104 or placebo IV on days 1 and 7

Drug: IRL201104; Drug: Placebo

Dose C IRL201104

EXPERIMENTAL

IRL201104 or placebo IV on days 1 and 7

Drug: IRL201104; Drug: Placebo

Interventions

IRL201104 DRUG

Lyophilised powder for reconstitution for IV dosing

Dose A IRL201104; Dose B IRL201104; Dose C IRL201104

Placebo DRUG

Matching placebo for IRL201104

Dose A IRL201104; Dose B IRL201104; Dose C IRL201104

Eligibility Criteria

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

You may qualify if:

• Participants must provide signed informed consent.
• Participants must be in good general health.
• Body mass index (BMI) 18 to ≤ 30 kg/m2.
• Contraception use by men or women .

You may not qualify if:

• Clinically significant liver, kidney disease or cardiac disease.
• Active malignancy and/or history of malignancy in the past 5 years.
• Serious local or systemic infection within 30 days prior to Screening
• Any acute illness within 30 days prior to Day 1.
• Surgery, bone fracture or major musculoskeletal injury within the 3 months.
• Abnormal screening laboratory tests.
• Positive for human immunodeficiency virus (HIV) antibody or antigen.
• Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
• Positive result indicating active SARS-CoV-2 infection on Day -1.
• Positive urine drug screen/alcohol breath test at Screening.
• Positive Quantiferon Tuberculosis (TB) test.
• Systolic blood pressure (BP) \> 150 mmHg or \< 90 mmHg or diastolic BP \> 90 mmHg or \< 50 mmHg. Heart rate \< 40 beats per minute (bpm) or \> 100 bpm.
• Prolonged QT interval corrected by Fridericia's formula (QTcF) (\> 450 ms for males and \> 470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the Investigator.
• All prescription and over-the-counter medications (including herbal medications), except for contraceptives and hormonal replacement therapy (HRT), are prohibited within 7 days prior to the first study intervention administration and throughout the entire duration of the study.
• All vaccines within 30 days prior and throughout the entire duration of the study.

Sponsors & Collaborators

• Revolo Biotherapeutics: lead

Study Sites (1)

Revolo Phase I site

Los Angeles, California, 90630, United States

Location

MeSH Terms

Interventions

IRL201104

Study Officials

• Anoshie Ratnayake, MD, MPH

  Revolo Biotherapeutics

  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: May 23, 2023
• First Posted: June 27, 2023
• Study Start: May 26, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (1)