Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler

NCT04534660

Nasolabial Fold Cheek Augmentation

COMPLETED NA

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants

NCT06868082

Healthy

RECRUITING PHASE1

Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA®

NCT05609617

Aging

COMPLETED NA

A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation

NCT04029545

Lip Augmentation

TERMINATED PHASE3

Investigation Into the Safety of Intradermal Juvidex (M6P) Administered to Wounds of Healthy Subjects

NCT00984854

Cicatrix Re-epithelialisation

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Group Type EXPERIMENTAL

REGN668: Injection Rate 1

Intervention Type DRUG

Subjects will receive REGN668 via SC injection

Group 2

Group Type EXPERIMENTAL

REGN668: Injection Rate 2

Intervention Type DRUG

Subjects will receive study drug via alternate delivery (if necessary)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REGN668: Injection Rate 1

Subjects will receive REGN668 via SC injection

Intervention Type DRUG

REGN668: Injection Rate 2

Subjects will receive study drug via alternate delivery (if necessary)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female subjects 18 to 55 years of age.
2. Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive.
3. NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination).
4. Normal resting blood pressure and heart rate
5. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.

Exclusion Criteria

1. History or presence of currently relevant medical conditions, including any cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, psychiatric, systemic, ocular, infectious or parasitic disease, or signs of acute illness.
2. Administration of any medications within 1 week before randomization, other than vitamins, nutritional supplements, or low doses of aspirin taken prophylactically.
3. Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to randomization. Subjects must be willing to maintain a relatively constant level of exercise during the study and refrain from unusually strenuous physical activities
4. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit.
5. History of substance (eg. drug or alcohol) abuse or regular (daily) smoking within a year prior to randomization or positive results on urine drug screen.
6. Excessive consumption of beverages with xanthine derivates (caffeine, theophylline, theobromine), such as coffee, tea, cola, or yerba mate (more than 4 cups or glasses per day).
7. Hospitalization for any reason within 60 days of randomization.
8. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of the investigational drug, whichever is longer, prior to the randomization visit.
9. Live/attenuated vaccinations within 12 weeks of randomization or during the study.
10. Tuberculosis vaccination within the last year.
11. Previous exposure to any other biological agent within 12 months of randomization.
12. History of a hypersensitivity reaction to doxycycline or other tetracyclines.
13. Recent travel (within 12 months of randomization) to areas endemic for parasitic helminthes, such as developing countries, particularly in Africa and the tropical and subtropical regions of Asia.
14. Pregnant or breast-feeding women.
15. Unwilling to use adequate birth control if of reproductive potential and sexually active

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes