A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety

In brief

This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects

Key facts

Study ID

NCT03955666

Run by

Provention Bio, Inc.

People needed

16

Starts

2019-08-07

Expected to finish

2019-12-11

Last updated by the study team

2023-08-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
• Body mass index (BMI) 18 to 32 kg/m2, inclusive.
• Male or female 18 to 50 years of age, inclusive.
• Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.

You may not qualify if…

• Women who are pregnant or breastfeeding.
• Evidence of active or chronic infections.
• Previous exposure to PRV-3279.
• Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.

Where it is running

• Clinical site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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