A phase I study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18660493

Enrollment

Registered

2007-05-10

Start date

2006-12-06

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies Infections and Infestations Rabies

Interventions

Part 1: The study subjects will receive one dose of CL184 intramuscularly at Day zero and will be followed up over 42 days. Part 2: The study subjects will receive one dose of CL184 on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers between 19 and 55 years of age 2. No previous treatment with rabies vaccine 3. Body Mass Index (BMI) between 20 and 28 kg/m^2

Exclusion criteria

Exclusion criteria: 1. Pregnant women, women planning to become pregnant and breastfeeding women 2. A history of or currently active clinically significant cardiac (including clinically significant abnormalities on Electrocardiogram [ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease

Design outcomes

Primary

Measure	Time frame
Safety and tolerability: this is assessed throughout the study, i.e., over 42 days.	—

Secondary

Measure	Time frame
1. Neutralising activity: this analysis is made at Day 14 and at all other timepoints up to Day 42. 2. Pharmacokinetics of CL184: this is a time-dependent parameter and analysis is performed over the full study duration, i.e., 42 days.	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026