Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
Public ClinicalTrials.gov record NCT04976855. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives for the study are: * Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers. * Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.
Study identification
- NCT ID
- NCT04976855
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2022
- Primary completion
- Jul 4, 2023
- Completion
- Jul 4, 2023
- Last update posted
- Aug 20, 2024
2022 – 2023
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins University School of Medicine BPRU | Baltimore | Maryland | 21224 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Healthy Volunteer trials
Other public records listing Healthy Volunteer. Sorted by last update posted; newest first. Not a recommendation.
- NCT07776782: A Single-Dose Study of MT-201 and Concomitant Infliximab in Healthy Participants Recruiting
- NCT07774650: A Study of the Pharmacokinetics, Biodistribution and Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled PET Radiotracers in Adult Healthy Volunteers Recruiting
- NCT02821806: Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy Recruiting
- NCT07756853: Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers Not yet recruiting
- NCT07680686: Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants Recruiting
- NCT07605806: Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04976855, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2024 · Synced Sep 11, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04976855 live on ClinicalTrials.gov.